Medications & Supplements/Prescription Drugs

Edge Pharma Recalls Various Medications for Sterility and Manufacturing Issues

Agency Publication Date: January 24, 2022

Summary

Edge Pharma, LLC is recalling 113,123 units of various sterile and non-sterile medications because they may lack assurance of sterility or have deviations from manufacturing standards. The recall includes a wide range of products such as ALUM Concentrate, Lidocaine, Vancomycin, and various dental and topical gels. These products were distributed nationwide to hospitals, clinics, and physician offices. No injuries or incidents have been reported to date.

Risk

Using products that are supposed to be sterile but are contaminated can lead to serious, life-threatening infections, especially when the drugs are injected or used in the eyes. Manufacturing defects in non-sterile medications also pose a risk of infection or unexpected side effects.

What You Should Do

This recall affects various sterile and non-sterile medications manufactured by Edge Pharma, LLC, including IV bags, pre-filled syringes, droppers, jars, and bottles.
Check your clinical inventory for products with the Edge Pharma, LLC label. Affected products include various medications such as Lidocaine, Vancomycin, Mitomycin-C, and multiple dental gels. See the Affected Products section below for the full list of affected codes.
Stop using the recalled products immediately.
Contact Edge Pharma, LLC or your distributor to arrange for the return of any remaining stock. If you have any medical questions regarding used products, contact a healthcare provider.
Healthcare providers who have administered these products should monitor patients for signs of infection or adverse reactions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag)

Variants: IV bag, Rx Only

Lot Numbers:

08-2021-25@2 (12/08/2021)

09-2021-08@1 (12/23/2021)

10-2021-20@3 (02/01/2022)

NDC:

05446-0637-03

Quantity: 30 bags

Product: Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe

Variants: Single Use Syringe, For Infiltration and Nerve Block

Lot Numbers:

08-2021-27@3 (12/09/2021)

09-2021-24@1 (01/06/2022)

10-2021-14@2 (01/31/2022)

NDC:

05446-0850-10

Quantity: 4465 syringes

Product: Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe

Variants: Single Use Syringe

Lot Numbers:

10-2021-25@4 (12/08/2021)

11-2021-08@6 (12/22/2021)

NDC:

05446-1268-01

Quantity: 8140 syringes

Product: Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL syringe)

Variants: Single Use Syringe, For Intraocular Injection

Lot Numbers:

09-2021-01@6 (12/14/2021)

10-2021-27@4 (01/01/2022)

NDC:

05446-0733-01

Quantity: 168 syringes

Product: Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL syringe

Variants: Single Use Syringe, For Intraocular Injection

Lot Numbers:

08-2021-30@1 (12/20/2021)

09-2021-21@5 (01/03/2022)

10-2021-18@5 (02/07/2022)

NDC:

05446-1003-01

Quantity: 1720 syringes

Product: Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL syringe

Variants: Single Use Syringe, For Otic Injection

Lot Numbers:

09-2021-28@1 (01/10/2022)

NDC:

05446-0848-01

Quantity: 323 syringes

Product: Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper

Variants: Single Dose Droptainer, Topical Ophthalmic Use

Lot Numbers:

10-2021-20@1 (02/10/2022)

NDC:

05446-1427-10

Quantity: 80 droppers

Product: Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper

Variants: Single Dose Droptainer, Topical Ophthalmic Use

Lot Numbers:

09-2021-22@1 (01/04/2022)

NDC:

05446-1428-10

Product: Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL syringe

Variants: Single Use Syringe, For Intraocular Injection

Lot Numbers:

10-2021-18@4 (12/08/2021)

11-2021-01@3 (12/22/2021)

NDC:

05446-0863-01

Quantity: 2568 syringes

Product: Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL syringe

Variants: Single Dose Syringe, For Intravesical Use

Lot Numbers:

08-2021-18@1 (12/14/2021)

08-2021-27@1 (12/09/2021)

09-2021-01@4 (12/14/2021)

09-2021-08@2 (12/21/2021)

09-2021-14@6 (01/05/2021)

09-2021-16@4 (12/29/2021)

09-2021-17@4 (12/30/2021)

09-2021-22@3 (01/04/2022)

10-2021-27@3 (02/08/2022)

NDC:

05446-1566-50

Quantity: 627 syringes

Product: Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution (PF), 2%/0.375%, 8 mL syringe

Variants: Single Use Syringe

Lot Numbers:

10-2021-26@3 (12/04/2021)

11-2021-09@1 (12/23/2021)

NDC:

05446-1548-18

Quantity: 1202 syringes

Product: Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL), 0.8 mL syringe

Variants: Single Use Syringe, For Intraocular Injection

Lot Numbers:

08-2021-31@2 (12/12/2021)

09-2021-20@4 (01/02/2022)

NDC:

05446-0736-01

Quantity: 3360 syringes

Product: Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag (Preservative Free), 250 mL

Variants: IV Injection

Lot Numbers:

09-2021-13@3 (12/27/2021)

09-2021-30@5 (01/13/2022)

NDC:

05446-1456-01

Quantity: 1795 bags

Product: Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,500 mg/500 mL, Single Use Bag (Preservative Free), 500 mL

Variants: IV Injection

Lot Numbers:

08-2021-26@4 (12/08/2021)

09-2021-21@3 (01/04/2022)

NDC:

05446-1458-01

Quantity: 1825 bags

Product: Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag (Preservative Free), 500 mL

Variants: IV Injection

Lot Numbers:

09-2021-09@6 (12/23/2021)

10-2021-13@5 (01/27/2022)

NDC:

05446-1459-01

Quantity: 749 bags

Product: Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, 30g jar

Variants: Multiple Dose Container, Topical Oral Use

Lot Numbers:

07-2021-13@7 (01/09/2022)

07-2021-27@8 (01/23/2022)

08-2021-10@5 (02/01/2022)

NDC:

05446-0408-10

Quantity: 175 jars

Product: Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL

Variants: Topical Solution

Lot Numbers:

07-2021-12@9 (01/08/2022)

08-2021-11@10 (02/07/2022)

08-2021-12@12 (02/08/2022)

09-2021-22@5 (03/21/2022)

10-2021-07@8 (04/05/2022)

10-2021-08@4 (04/06/2022)

11-2021-01@7 (04/30/2022)

NDC:

05446-1211-03

Quantity: 1861 jars

Product: Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL bottle

Variants: Multiple Dose Container, Nasal Solution

Lot Numbers:

07-2021-02@7 (12/29/2021)

07-2021-23@4 (01/19/2022)

08-2021-11@7 (02/07/2022)

08-2021-23@8 (02/19/2022)

09-2021-24@10 (03/23/2022)

NDC:

05446-1045-03

Quantity: 231 bottles

Product: Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL syringe

Variants: Single Dose Syringe, Oral Use

Lot Numbers:

10-2021-11@6 (01/09/2022)

11-2021-01@8 (01/30/2022)

NDC:

05446-1132-03

Quantity: 757 syringes

Product: Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL syringe

Variants: Single Dose Syringe, Topical Use Only

Lot Numbers:

08-2021-02@9 (12/15/2021)

08-2021-16@10 (12/29/2021)

09-2021-08@6 (01/21/2022)

09-2021-20@6 (02/02/2022)

10-2021-18@6 (03/02/2022)

NDC:

05446-1341-01

Quantity: 7788 syringes

Product: Tetracaine HCl Nasal Solution, 4%, 240 mL bottle

Variants: Multiple Dose Container, Intranasal Use

Lot Numbers:

06-2021-08@5 (12/05/2021)

07-2021-07@7 (01/03/2022)

07-2021-27@10 (01/23/2022)

10-2021-06@12 (04/04/2022)

NDC:

05446-1195-03

Quantity: 114 bottles

Product: Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL syringe

Variants: Single Dose Syringe, Oral Use Only

Lot Numbers:

09-2021-10@3 (12/09/2021)

09-2021-17@6 (12/16/2021)

09-2021-24@8 (12/23/2021)

09-2021-30@7 (12/29/2021)

10-2021-13@6 (01/11/2022)

NDC:

05446-1348-01

Quantity: 6925 syringes

Product: Trypan Blue 0.03%, 0.5mL syringe, Sterile Ophthalmic Solution

Variants: Preservative Free, Single Use Syringe, For Intraocular Injection

Lot Numbers:

09-2021-10@3 (12/09/2021)

09-2021-17@6 (12/16/2021)

09-2021-24@8 (12/23/2021)

09-2021-30@7 (12/29/2021)

10-2021-13@6 (01/11/2022)

NDC:

05446-1348-01

Product: Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, PF

Variants: 3 mL per syringe, Test Kit

Lot Numbers:

09-2021-03@6 (12/16/2021)

10-2021-06@7 (01/18/2022)

NDC:

05446-1600-05

Quantity: 1007 syringes

Product: Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL syringe

Variants: Single Use Syringe

Lot Numbers:

09-2021-10@2 (12/23/2021)

10-2021-21@2 (02/01/2022)

11-2021-09@5 (02/21/2022)

NDC:

05446-1505-05

Quantity: 457 syringes

Product: Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL syringe

Variants: Single Dose Syringe, For Intravesical Use

Lot Numbers:

08-2021-24@5 (12/09/2021)

08-2021-27@2 (12/21/2021)

08-2021-31@5 (12/14/2021)

09-2021-02@2 (12/15/2021)

09-2021-09@2 (12/22/2021)

09-2021-15@3 (12/29/2021)

09-2021-22@2 (01/04/2022)

10-2021-26@5 (02/07/2022)

NDC:

05446-1416-01

Quantity: 860 syringes

Product: Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL syringe

Variants: Single Use Syringe, Topical Ophthalmic Use

Lot Numbers:

11-2021-08@8 (12/18/2021)

NDC:

05446-1009-01

Quantity: 163 syringes

Product: Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL syringe

Variants: Single Use Syringe, Topical Ophthalmic Use

Lot Numbers:

11-2021-08@9 (12/18/2021)

NDC:

05446-1011-01

Quantity: 154 syringes

Product: Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL syringe

Variants: Single Use Syringe, For Intraocular Injection

Lot Numbers:

08-2021-26@2 (12/09/2021)

09-2021-23@1 (01/05/2022)

NDC:

05446-1050-01

Quantity: 860 syringes

Product: Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL syringe

Variants: Single Use Syringe, For IV or IM Injection

Lot Numbers:

10-2021-07@1 (01/19/2022)

NDC:

05446-1549-05

Quantity: 160 syringes

Product: MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL, 0.13 mL syringe

Variants: Single Use Syringe, For Intraocular Injection

Lot Numbers:

11-2021-01@2 (12/15/2021)

NDC:

05446-1661-13

Quantity: 199 syringes

Product: Phenol, Sterile Solution for Injection (PF), 6%, 5 mL vial

Variants: Single Use Vial, For Perineural Injection

Lot Numbers:

09-2021-14@5 (12/29/2021)

11-2021-04@2 (02/15/2022)

NDC:

05446-1476-05

Quantity: 309 vials

Product: Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL syringe

Variants: Single Use Syringe, Topical Ophthalmic Use

Lot Numbers:

08-2021-31@8 (12/21/2021)

10-2021-13@1 (01/19/2022)

NDC:

05446-1270-01

Quantity: 2463 vials

Product: Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL syringe

Variants: Single Use Syringe, For IV Injection

Lot Numbers:

09-2021-09@4 (12/22/2021)

10-2021-14@1 (01/26/2022)

NDC:

05446-1545-05

Quantity: 3747 syringes

Product: Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL syringe

Variants: Single Use Syringe, For IV Injection

Lot Numbers:

08-2021-26@3 (12/16/2021)

09-2021-16@5 (12/29/2021)

10-2021-07@2 (01/19/2022)

10-2021-22@1 (02/03/2022)

NDC:

05446-1544-10

Quantity: 6535 vials

Product: Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), syringe

Variants: Single Use Syringe, For IV Injection

Lot Numbers:

08-2021-27@4 (12/09/2021)

09-2021-17@1 (12/30/2021)

10-2021-15@1 (01/27/2022)

10-2021-28@1 (02/09/2022)

NDC:

05446-1652-01

Quantity: 5335 syringes

Product: PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), 250mL bag

Variants: Single use bag, For IV injection (PF)

Lot Numbers:

08-2021-24@6 (12/06/2021)

08-2021-31@7 (12/12/2021)

09-2021-07@3 (12/21/2021)

10-2021-20@2 (02/02/2022)

10-2021-28@2 (02/10/2022)

NDC:

05446-1667-01

Quantity: 3930 bags

Product: Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL syringe

Variants: Single Use Syringe, For Intraocular Injection

Lot Numbers:

09-2021-16@1 (12/29/2021)

NDC:

05446-1118-01

Quantity: 2750 syringes

Product: Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL dropper

Variants: Multiple Dose Droptainer, Topical Ophthalmic Use

Lot Numbers:

09-2021-15@1 (12/28/2021)

NDC:

05446-0815-01

Quantity: 363 droptainers

Product: Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe

Variants: Single Use Syringe, Topical Ophthalmic Use

Lot Numbers:

09-2021-15@2 (12/28/2021)

11-2021-02@3 (02/14/2022)

NDC:

05446-0993-01

Quantity: 2562 syringes

Product: Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL dropper

Variants: Multiple Dose Droptainer, Topical Ophthalmic Use

Lot Numbers:

11-2021-02@2 (12/16/2021)

NDC:

05446-0859-03

Quantity: 40 droptainers

Product: Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL syringe

Variants: Single Use Syringe, Topical Ophthalmic Use

Lot Numbers:

10-2021-25@5 (12/09/2021)

NDC:

05446-1680-01

Quantity: 1773 syringes

Product: BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm jar

Variants: Multiple Dose Container, Topical Use

Lot Numbers:

06-2021-10@11 (12/07/2021)

06-2021-10@9 (12/07/2021)

06-2021-17@6 (12/14/2021)

06-2021-17@7 (12/14/2021)

06-2021-24@5 (12/21/2021)

06-2021-24@8 (12/21/2021)

07-2021-01@6 (12/28/2021)

07-2021-01@7 (12/28/2021)

07-2021-09@5 (01/01/2022)

07-2021-09@6 (01/05/2022)

07-2021-15@5 (01/01/2022)

07-2021-15@6 (01/01/2022)

07-2021-22@16 (01/19/2022)

07-2021-22@8 (01/01/2022)

07-2021-29@12 (01/25/2022)

07-2021-29@24 (01/25/2022)

08-2021-05@7 (02/01/2022)

08-2021-05@8 (02/01/2022)

08-2021-19@7 (02/15/2022)

08-2021-19@8 (02/15/2022)

08-2021-26@5 (02/22/2022)

09-2021-01@10 (02/28/2022)

09-2021-03@7 (03/02/2022)

09-2021-09@7 (03/08/2022)

09-2021-16@7 (03/15/2022)

09-2021-17@7 (03/16/2022)

09-2021-22@8 (03/21/2021)

09-2021-23@2 (03/22/2022)

09-2021-23@3 (03/22/2022)

09-2021-30@10 (03/29/2022)

09-2021-30@8 (03/29/2022)

10-2021-07@10 (04/05/2022)

10-2021-07@7 (04/05/2022)

10-2021-08@1 (04/06/2022)

10-2021-14@4 (04/12/2022)

10-2021-14@5 (04/12/2022)

10-2021-21@7 (04/19/2022)

10-2021-28@3 (04/26/2022)

NDC:

05446-1235-01

Quantity: 1173 jars

Product: Cantharidin Gel-Forming Suspension, 0.7%, 10 mL vial

Variants: Multiple Dose Vial, Topical Use

Lot Numbers:

06-2021-11@6 (12/08/2021)

07-2021-08@13 (01/04/2022)

08-2021-06@6 (02/02/2022)

08-2021-20@10 (02/16/2022)

08-2021-26@6 (02/22/2022)

08-2021-27@7 (02/23/2022)

09-2021-02@5 (03/01/2022)

09-2021-17@8 (03/16/2022)

09-2021-29@12 (03/28/2022)

NDC:

05446-0572-03

Quantity: 1173 vials

Product: Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL vial

Variants: Multiple Dose Vials, Topical Use

Lot Numbers:

06-2021-09@9 (12/06/2021)

06-2021-16@11 (12/13/2021)

06-2021-23@7 (12/20/2021)

06-2021-30@11 (12/27/2021)

07-2021-07@9 (01/03/2022)

07-2021-13@6 (01/09/2021)

07-2021-14@5 (01/10/2022)

07-2021-21@8 (01/17/2022)

07-2021-26@10 (01/22/2022)

08-2021-04@5 (01/31/2022)

08-2021-09@11 (02/05/2022)

08-2021-10@6 (02/06/2022)

08-2021-17@5 (02/13/2022)

08-2021-25@4 (02/21/2022)

09-2021-01@8 (02/28/2022)

09-2021-08@8 (03/07/2022)

09-2021-15@6 (03/14/2022)

09-2021-21@8 (03/20/2022)

09-2021-27@10 (03/26/2022)

10-2021-06@8 (04/04/2022)

10-2021-13@7 (04/11/2022)

10-2021-20@7 (04/18/2022)

10-2021-20@9 (04/18/2021)

10-2021-26@9 (04/24/2022)

NDC:

05446-0970-03

Quantity: 2204 vials

Product: CSF Otic Insufflation Capsule, 50mg / 30mg / 5mg, 5 count bottle

Variants: Otic Powder, For Otic Use with Insufflator

Lot Numbers:

10-2021-27@8 (01-25-2022)

NDC:

05446-1633-05

Quantity: 1055 bottles

Product: CSF-HC Otic Insufflation Capsule, 50mg/ 30mg/ 25mg/ 5mg, 5 count bottle

Variants: Otic Powder

Lot Numbers:

10-2021-05@9 (01/01/2022)

10-2021-28@4 (01/26/2022)

NDC:

05446-1634-01

Quantity: 440 cartons

Product: Dexamethasone sodium phosphate 0.4%, 120 mL bottle

Variants: Multiple Dose Container, Topical Use

Lot Numbers:

06-2021-23@6 (12/20/2021)

09-2021-15@4 (03/14/2022)

10-2021-04@10 (04/02/2022)

NDC:

05446-0622-01

Quantity: 56 cartons

Product: Dibutyl Squaric Acid, Topical Solution (PF), 2%, 10 mL vial

Variants: Multiple Dose Vial

Lot Numbers:

09-2021-15@5 (12/14/2021)

10-2021-01@4 (12/30/2021)

NDC:

05446-1047-03

Quantity: 63 vials

Product: Dibutyl Squaric Acid, Topical Solution (PF), 1%, 10 mL vial

Variants: Multiple Dose Vial

Lot Numbers:

08-2021-03@8 (12/31/2021)

09-2021-07@10 (02/04/2022)

NDC:

05446-1156-03

Quantity: 20 vials

Product: LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm jar

Variants: Multiple Dose Container, Topical Use

Lot Numbers:

08-2021-23@9 (02/19/2022)

09-2021-07@13 (03/06/2022)

10-2021-22@5 (04/20/2022)

NDC:

05446-1647-01

Quantity: 74 jars

Product: LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL syringe

Variants: Single Dose Syringe, Topical Use

Lot Numbers:

07-2021-12@6 (12/09/2021)

07-2021-19@7 (12/16/2021)

07-2021-26@5 (12/23/2021)

08-2021-02@8 (12/30/2021)

08-2021-09@10 (01/06/2022)

08-2021-13@6 (01/10/2022)

08-2021-18@4 (01/15/2022)

08-2021-24@8 (01/21/2022)

08-2021-30@5 (01/27/2022)

09-2021-07@11 (02/04/2022)

09-2021-13@5 (02/10/2022)

10-2021-04@9 (03/03/2022)

NDC:

05446-0607-01

Quantity: 26917 syringes

Product: Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL bottle

Variants: Multiple Dose Container, Intranasal Use

Lot Numbers:

06-2021-18@3 (12/15/2021)

06-2021-30@10 (12/27/2021)

07-2021-14@4 (01/10/2022)

07-2021-21@4 (01/17/2022)

07-2021-28@9 (01/24/2022)

08-2021-12@8 (02/08/2022)

08-2021-24@9 (02/20/2022)

09-2021-09@10 (03/08/2022)

10-2021-05@6 (04/03/2022)

NDC:

05446-1256-01

Quantity: 386 bottles

Product: Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, Raspberry Marshmallow, 30g jar

Variants: Multiple Dose Container, Topical Oral Use

Lot Numbers:

07-2021-20@7 (01/16/2022)

08-2021-11@6 (02/07/2022)

08-2021-31@11 (02/01/2022)

09-2021-14@11 (02/01/2022)

09-2021-21@6 (02/01/2022)

10-2021-12@4 (04/10/2022)

NDC:

05446-0790-10

Quantity: 353 jars

Product: Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, Spearmint-Peppermint, 30g jar

Variants: Multiple Dose Container, Topical Oral Use

Lot Numbers:

08-2021-16@12 (02/01/2022)

09-2021-13@8 (02/01/2022)

09-2021-29@8 (03/01/2022)

10-2021-26@7 (04/24/2022)

NDC:

05446-0407-10

Quantity: 221 jars

Product: Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, Raspberry-Marshmallow, jar

Variants: Multiple Dose Container, Topical Oral Use

Lot Numbers:

06-2021-29@15 (12/26/2021)

07-2021-12@7 (01/08/2022)

08-2021-03@7 (01/30/2022)

08-2021-25@5 (02/01/2022)

09-2021-10@4 (02/01/2022)

09-2021-22@6 (03/01/2022)

10-2021-06@11 (04/04/2022)

NDC:

05446-1018-10

Quantity: 418 jars

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89172

Status: Resolved

Manufacturer: Edge Pharma, LLC

Sold By: hospitals; clinics; physician offices

Manufactured In: United States

Units Affected: 54 products (30 bags; 4465 syringes; 8140 syringes; 168 syringes; 1720 syringes; 323 syringes; 80 droppers; 2568 syringes; 627 syringes; 1202 syringes; 1007 syringes; 457 syringes; 860 syringes; 163 syringes; 154 syringes; 860 syringes; 160 syringes; 199 syringes; 309 vials; 2463 vials; 3747 syringes; 6535 vials; 5335 syringes; 3930 bags; 2750 syringes; 363 droptainers; 2562 syringes; 40 droptainers; 1773 syringes; 3360 syringes; 1795 bags; 1825 bags; 749 bags; 1173 jars; 1173 vials; 2204 vials; 1055 bottles; 440 cartons; 56 cartons; 63 vials; 20 vials; 74 jars; 26917 syringes; 386 bottles; 353 jars; 221 jars; 418 jars; 175 jars; 1861 jars; 231 bottles; 757 syringes; 7788 syringes; 114 bottles; 6925 syringes)

Distributed To: Nationwide

Agency Last Updated: January 31, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects various sterile and non-sterile medications manufactured by Edge Pharma, LLC, including IV bags, pre-filled syringes, droppers, jars, and bottles.

Check your clinical inventory for products with the Edge Pharma, LLC label. Affected products include various medications such as Lidocaine, Vancomycin, Mitomycin-C, and multiple dental gels. See the Affected Products section below for the full list of affected codes.

Stop using the recalled products immediately.

Contact Edge Pharma, LLC or your distributor to arrange for the return of any remaining stock. If you have any medical questions regarding used products, contact a healthcare provider.

Healthcare providers who have administered these products should monitor patients for signs of infection or adverse reactions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Affected Products

Product: ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag)

Variants: IV bag, Rx Only

Lot Numbers:

08-2021-25@2 (12/08/2021)

09-2021-08@1 (12/23/2021)

10-2021-20@3 (02/01/2022)

NDC:

05446-0637-03

Quantity: 30 bags

Product: Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe

Variants: Single Use Syringe, For Infiltration and Nerve Block

Lot Numbers:

08-2021-27@3 (12/09/2021)

09-2021-24@1 (01/06/2022)

10-2021-14@2 (01/31/2022)

NDC:

05446-0850-10

Quantity: 4465 syringes

Product: Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe

Variants: Single Use Syringe

Lot Numbers:

10-2021-25@4 (12/08/2021)

11-2021-08@6 (12/22/2021)

NDC:

05446-1268-01

Quantity: 8140 syringes

Product: Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL syringe)

Variants: Single Use Syringe, For Intraocular Injection

Lot Numbers:

09-2021-01@6 (12/14/2021)

10-2021-27@4 (01/01/2022)

NDC:

05446-0733-01

Quantity: 168 syringes

Product: Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL syringe

Variants: Single Use Syringe, For Intraocular Injection

Lot Numbers:

08-2021-30@1 (12/20/2021)

09-2021-21@5 (01/03/2022)

10-2021-18@5 (02/07/2022)

NDC:

05446-1003-01

Quantity: 1720 syringes

Product: Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL syringe

Variants: Single Use Syringe, For Otic Injection

Lot Numbers:

09-2021-28@1 (01/10/2022)

NDC:

05446-0848-01

Quantity: 323 syringes

Product: Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper

Variants: Single Dose Droptainer, Topical Ophthalmic Use

Lot Numbers:

10-2021-20@1 (02/10/2022)

NDC:

05446-1427-10

Quantity: 80 droppers

Product: Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper

Variants: Single Dose Droptainer, Topical Ophthalmic Use

Lot Numbers:

09-2021-22@1 (01/04/2022)

NDC:

05446-1428-10

Product: Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL syringe

Variants: Single Use Syringe, For Intraocular Injection

Lot Numbers:

10-2021-18@4 (12/08/2021)

11-2021-01@3 (12/22/2021)

NDC:

05446-0863-01

Quantity: 2568 syringes

Product: Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL syringe

Variants: Single Dose Syringe, For Intravesical Use

Lot Numbers:

08-2021-18@1 (12/14/2021)

08-2021-27@1 (12/09/2021)

09-2021-01@4 (12/14/2021)

09-2021-08@2 (12/21/2021)

09-2021-14@6 (01/05/2021)

09-2021-16@4 (12/29/2021)

09-2021-17@4 (12/30/2021)

09-2021-22@3 (01/04/2022)

10-2021-27@3 (02/08/2022)

NDC:

05446-1566-50

Quantity: 627 syringes

Product: Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution (PF), 2%/0.375%, 8 mL syringe

Variants: Single Use Syringe

Lot Numbers:

10-2021-26@3 (12/04/2021)

11-2021-09@1 (12/23/2021)

NDC:

05446-1548-18

Quantity: 1202 syringes

Product: Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL), 0.8 mL syringe

Variants: Single Use Syringe, For Intraocular Injection

Lot Numbers:

08-2021-31@2 (12/12/2021)

09-2021-20@4 (01/02/2022)

NDC:

05446-0736-01

Quantity: 3360 syringes

Product: Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag (Preservative Free), 250 mL

Variants: IV Injection

Lot Numbers:

09-2021-13@3 (12/27/2021)

09-2021-30@5 (01/13/2022)

NDC:

05446-1456-01

Quantity: 1795 bags

Product: Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,500 mg/500 mL, Single Use Bag (Preservative Free), 500 mL

Variants: IV Injection

Lot Numbers:

08-2021-26@4 (12/08/2021)

09-2021-21@3 (01/04/2022)

NDC:

05446-1458-01

Quantity: 1825 bags

Product: Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag (Preservative Free), 500 mL

Variants: IV Injection

Lot Numbers:

09-2021-09@6 (12/23/2021)

10-2021-13@5 (01/27/2022)

NDC:

05446-1459-01

Quantity: 749 bags

Product: Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, 30g jar

Variants: Multiple Dose Container, Topical Oral Use

Lot Numbers:

07-2021-13@7 (01/09/2022)

07-2021-27@8 (01/23/2022)

08-2021-10@5 (02/01/2022)

NDC:

05446-0408-10

Quantity: 175 jars

Product: Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL

Variants: Topical Solution

Lot Numbers:

07-2021-12@9 (01/08/2022)

08-2021-11@10 (02/07/2022)

08-2021-12@12 (02/08/2022)

09-2021-22@5 (03/21/2022)

10-2021-07@8 (04/05/2022)

10-2021-08@4 (04/06/2022)

11-2021-01@7 (04/30/2022)

NDC:

05446-1211-03

Quantity: 1861 jars

Product: Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL bottle

Variants: Multiple Dose Container, Nasal Solution

Lot Numbers:

07-2021-02@7 (12/29/2021)

07-2021-23@4 (01/19/2022)

08-2021-11@7 (02/07/2022)

08-2021-23@8 (02/19/2022)

09-2021-24@10 (03/23/2022)

NDC:

05446-1045-03

Quantity: 231 bottles

Product: Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL syringe

Variants: Single Dose Syringe, Oral Use

Lot Numbers:

10-2021-11@6 (01/09/2022)

11-2021-01@8 (01/30/2022)

NDC:

05446-1132-03

Quantity: 757 syringes

Product: Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL syringe

Variants: Single Dose Syringe, Topical Use Only

Lot Numbers:

08-2021-02@9 (12/15/2021)

08-2021-16@10 (12/29/2021)

09-2021-08@6 (01/21/2022)

09-2021-20@6 (02/02/2022)

10-2021-18@6 (03/02/2022)

NDC:

05446-1341-01

Quantity: 7788 syringes

Product: Tetracaine HCl Nasal Solution, 4%, 240 mL bottle

Variants: Multiple Dose Container, Intranasal Use

Lot Numbers:

06-2021-08@5 (12/05/2021)

07-2021-07@7 (01/03/2022)

07-2021-27@10 (01/23/2022)

10-2021-06@12 (04/04/2022)

NDC:

05446-1195-03

Quantity: 114 bottles

Product: Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL syringe

Variants: Single Dose Syringe, Oral Use Only

Lot Numbers:

09-2021-10@3 (12/09/2021)

09-2021-17@6 (12/16/2021)

09-2021-24@8 (12/23/2021)

09-2021-30@7 (12/29/2021)

10-2021-13@6 (01/11/2022)

NDC:

05446-1348-01

Quantity: 6925 syringes

Product: Trypan Blue 0.03%, 0.5mL syringe, Sterile Ophthalmic Solution

Variants: Preservative Free, Single Use Syringe, For Intraocular Injection

Lot Numbers:

09-2021-10@3 (12/09/2021)

09-2021-17@6 (12/16/2021)

09-2021-24@8 (12/23/2021)

09-2021-30@7 (12/29/2021)

10-2021-13@6 (01/11/2022)

NDC:

05446-1348-01

Product: Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, PF

Variants: 3 mL per syringe, Test Kit

Lot Numbers:

09-2021-03@6 (12/16/2021)

10-2021-06@7 (01/18/2022)

NDC:

05446-1600-05

Quantity: 1007 syringes

Product: Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL syringe

Variants: Single Use Syringe

Lot Numbers:

09-2021-10@2 (12/23/2021)

10-2021-21@2 (02/01/2022)

11-2021-09@5 (02/21/2022)

NDC:

05446-1505-05

Quantity: 457 syringes

Product: Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL syringe

Variants: Single Dose Syringe, For Intravesical Use

Lot Numbers:

08-2021-24@5 (12/09/2021)

08-2021-27@2 (12/21/2021)

08-2021-31@5 (12/14/2021)

09-2021-02@2 (12/15/2021)

09-2021-09@2 (12/22/2021)

09-2021-15@3 (12/29/2021)

09-2021-22@2 (01/04/2022)

10-2021-26@5 (02/07/2022)

NDC:

05446-1416-01

Quantity: 860 syringes

Product: Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL syringe

Variants: Single Use Syringe, Topical Ophthalmic Use

Lot Numbers:

11-2021-08@8 (12/18/2021)

NDC:

05446-1009-01

Quantity: 163 syringes

Product: Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL syringe

Variants: Single Use Syringe, Topical Ophthalmic Use

Lot Numbers:

11-2021-08@9 (12/18/2021)

NDC:

05446-1011-01

Quantity: 154 syringes

Product: Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL syringe

Variants: Single Use Syringe, For Intraocular Injection

Lot Numbers:

08-2021-26@2 (12/09/2021)

09-2021-23@1 (01/05/2022)

NDC:

05446-1050-01

Quantity: 860 syringes

Product: Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL syringe

Variants: Single Use Syringe, For IV or IM Injection

Lot Numbers:

10-2021-07@1 (01/19/2022)

NDC:

05446-1549-05

Quantity: 160 syringes

Product: MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL, 0.13 mL syringe

Variants: Single Use Syringe, For Intraocular Injection

Lot Numbers:

11-2021-01@2 (12/15/2021)

NDC:

05446-1661-13

Quantity: 199 syringes

Product: Phenol, Sterile Solution for Injection (PF), 6%, 5 mL vial

Variants: Single Use Vial, For Perineural Injection

Lot Numbers:

09-2021-14@5 (12/29/2021)

11-2021-04@2 (02/15/2022)

NDC:

05446-1476-05

Quantity: 309 vials

Product: Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL syringe

Variants: Single Use Syringe, Topical Ophthalmic Use

Lot Numbers:

08-2021-31@8 (12/21/2021)

10-2021-13@1 (01/19/2022)

NDC:

05446-1270-01

Quantity: 2463 vials

Product: Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL syringe

Variants: Single Use Syringe, For IV Injection

Lot Numbers:

09-2021-09@4 (12/22/2021)

10-2021-14@1 (01/26/2022)

NDC:

05446-1545-05

Quantity: 3747 syringes

Product: Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL syringe

Variants: Single Use Syringe, For IV Injection

Lot Numbers:

08-2021-26@3 (12/16/2021)

09-2021-16@5 (12/29/2021)

10-2021-07@2 (01/19/2022)

10-2021-22@1 (02/03/2022)

NDC:

05446-1544-10

Quantity: 6535 vials

Product: Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), syringe

Variants: Single Use Syringe, For IV Injection

Lot Numbers:

08-2021-27@4 (12/09/2021)

09-2021-17@1 (12/30/2021)

10-2021-15@1 (01/27/2022)

10-2021-28@1 (02/09/2022)

NDC:

05446-1652-01

Quantity: 5335 syringes

Product: PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), 250mL bag

Variants: Single use bag, For IV injection (PF)

Lot Numbers:

08-2021-24@6 (12/06/2021)

08-2021-31@7 (12/12/2021)

09-2021-07@3 (12/21/2021)

10-2021-20@2 (02/02/2022)

10-2021-28@2 (02/10/2022)

NDC:

05446-1667-01

Quantity: 3930 bags

Product: Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL syringe

Variants: Single Use Syringe, For Intraocular Injection

Lot Numbers:

09-2021-16@1 (12/29/2021)

NDC:

05446-1118-01

Quantity: 2750 syringes

Product: Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL dropper

Variants: Multiple Dose Droptainer, Topical Ophthalmic Use

Lot Numbers:

09-2021-15@1 (12/28/2021)

NDC:

05446-0815-01

Quantity: 363 droptainers

Product: Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe

Variants: Single Use Syringe, Topical Ophthalmic Use

Lot Numbers:

09-2021-15@2 (12/28/2021)

11-2021-02@3 (02/14/2022)

NDC:

05446-0993-01

Quantity: 2562 syringes

Product: Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL dropper

Variants: Multiple Dose Droptainer, Topical Ophthalmic Use

Lot Numbers:

11-2021-02@2 (12/16/2021)

NDC:

05446-0859-03

Quantity: 40 droptainers

Product: Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL syringe

Variants: Single Use Syringe, Topical Ophthalmic Use

Lot Numbers:

10-2021-25@5 (12/09/2021)

NDC:

05446-1680-01

Quantity: 1773 syringes

Product: BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm jar

Variants: Multiple Dose Container, Topical Use

Lot Numbers:

06-2021-10@11 (12/07/2021)

06-2021-10@9 (12/07/2021)

06-2021-17@6 (12/14/2021)

06-2021-17@7 (12/14/2021)

06-2021-24@5 (12/21/2021)

06-2021-24@8 (12/21/2021)

07-2021-01@6 (12/28/2021)

07-2021-01@7 (12/28/2021)

07-2021-09@5 (01/01/2022)

07-2021-09@6 (01/05/2022)

07-2021-15@5 (01/01/2022)

07-2021-15@6 (01/01/2022)

07-2021-22@16 (01/19/2022)

07-2021-22@8 (01/01/2022)

07-2021-29@12 (01/25/2022)

07-2021-29@24 (01/25/2022)

08-2021-05@7 (02/01/2022)

08-2021-05@8 (02/01/2022)

08-2021-19@7 (02/15/2022)

08-2021-19@8 (02/15/2022)

08-2021-26@5 (02/22/2022)

09-2021-01@10 (02/28/2022)

09-2021-03@7 (03/02/2022)

09-2021-09@7 (03/08/2022)

09-2021-16@7 (03/15/2022)

09-2021-17@7 (03/16/2022)

09-2021-22@8 (03/21/2021)

09-2021-23@2 (03/22/2022)

09-2021-23@3 (03/22/2022)

09-2021-30@10 (03/29/2022)

09-2021-30@8 (03/29/2022)

10-2021-07@10 (04/05/2022)

10-2021-07@7 (04/05/2022)

10-2021-08@1 (04/06/2022)

10-2021-14@4 (04/12/2022)

10-2021-14@5 (04/12/2022)

10-2021-21@7 (04/19/2022)

10-2021-28@3 (04/26/2022)

NDC:

05446-1235-01

Quantity: 1173 jars

Product: Cantharidin Gel-Forming Suspension, 0.7%, 10 mL vial

Variants: Multiple Dose Vial, Topical Use

Lot Numbers:

06-2021-11@6 (12/08/2021)

07-2021-08@13 (01/04/2022)

08-2021-06@6 (02/02/2022)

08-2021-20@10 (02/16/2022)

08-2021-26@6 (02/22/2022)

08-2021-27@7 (02/23/2022)

09-2021-02@5 (03/01/2022)

09-2021-17@8 (03/16/2022)

09-2021-29@12 (03/28/2022)

NDC:

05446-0572-03

Quantity: 1173 vials

Product: Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL vial

Variants: Multiple Dose Vials, Topical Use

Lot Numbers:

06-2021-09@9 (12/06/2021)

06-2021-16@11 (12/13/2021)

06-2021-23@7 (12/20/2021)

06-2021-30@11 (12/27/2021)

07-2021-07@9 (01/03/2022)

07-2021-13@6 (01/09/2021)

07-2021-14@5 (01/10/2022)

07-2021-21@8 (01/17/2022)

07-2021-26@10 (01/22/2022)

08-2021-04@5 (01/31/2022)

08-2021-09@11 (02/05/2022)

08-2021-10@6 (02/06/2022)

08-2021-17@5 (02/13/2022)

08-2021-25@4 (02/21/2022)

09-2021-01@8 (02/28/2022)

09-2021-08@8 (03/07/2022)

09-2021-15@6 (03/14/2022)

09-2021-21@8 (03/20/2022)

09-2021-27@10 (03/26/2022)

10-2021-06@8 (04/04/2022)

10-2021-13@7 (04/11/2022)

10-2021-20@7 (04/18/2022)

10-2021-20@9 (04/18/2021)

10-2021-26@9 (04/24/2022)

NDC:

05446-0970-03

Quantity: 2204 vials

Product: CSF Otic Insufflation Capsule, 50mg / 30mg / 5mg, 5 count bottle

Variants: Otic Powder, For Otic Use with Insufflator

Lot Numbers:

10-2021-27@8 (01-25-2022)

NDC:

05446-1633-05

Quantity: 1055 bottles

Product: CSF-HC Otic Insufflation Capsule, 50mg/ 30mg/ 25mg/ 5mg, 5 count bottle

Variants: Otic Powder

Lot Numbers:

10-2021-05@9 (01/01/2022)

10-2021-28@4 (01/26/2022)

NDC:

05446-1634-01

Quantity: 440 cartons

Product: Dexamethasone sodium phosphate 0.4%, 120 mL bottle

Variants: Multiple Dose Container, Topical Use

Lot Numbers:

06-2021-23@6 (12/20/2021)

09-2021-15@4 (03/14/2022)

10-2021-04@10 (04/02/2022)

NDC:

05446-0622-01

Quantity: 56 cartons

Product: Dibutyl Squaric Acid, Topical Solution (PF), 2%, 10 mL vial

Variants: Multiple Dose Vial

Lot Numbers:

09-2021-15@5 (12/14/2021)

10-2021-01@4 (12/30/2021)

NDC:

05446-1047-03

Quantity: 63 vials

Product: Dibutyl Squaric Acid, Topical Solution (PF), 1%, 10 mL vial

Variants: Multiple Dose Vial

Lot Numbers:

08-2021-03@8 (12/31/2021)

09-2021-07@10 (02/04/2022)

NDC:

05446-1156-03

Quantity: 20 vials

Product: LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm jar

Variants: Multiple Dose Container, Topical Use

Lot Numbers:

08-2021-23@9 (02/19/2022)

09-2021-07@13 (03/06/2022)

10-2021-22@5 (04/20/2022)

NDC:

05446-1647-01

Quantity: 74 jars

Product: LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL syringe

Variants: Single Dose Syringe, Topical Use

Lot Numbers:

07-2021-12@6 (12/09/2021)

07-2021-19@7 (12/16/2021)

07-2021-26@5 (12/23/2021)

08-2021-02@8 (12/30/2021)

08-2021-09@10 (01/06/2022)

08-2021-13@6 (01/10/2022)

08-2021-18@4 (01/15/2022)

08-2021-24@8 (01/21/2022)

08-2021-30@5 (01/27/2022)

09-2021-07@11 (02/04/2022)

09-2021-13@5 (02/10/2022)

10-2021-04@9 (03/03/2022)

NDC:

05446-0607-01

Quantity: 26917 syringes

Product: Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL bottle

Variants: Multiple Dose Container, Intranasal Use

Lot Numbers:

06-2021-18@3 (12/15/2021)

06-2021-30@10 (12/27/2021)

07-2021-14@4 (01/10/2022)

07-2021-21@4 (01/17/2022)

07-2021-28@9 (01/24/2022)

08-2021-12@8 (02/08/2022)

08-2021-24@9 (02/20/2022)

09-2021-09@10 (03/08/2022)

10-2021-05@6 (04/03/2022)

NDC:

05446-1256-01

Quantity: 386 bottles

Product: Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, Raspberry Marshmallow, 30g jar

Variants: Multiple Dose Container, Topical Oral Use

Lot Numbers:

07-2021-20@7 (01/16/2022)

08-2021-11@6 (02/07/2022)

08-2021-31@11 (02/01/2022)

09-2021-14@11 (02/01/2022)

09-2021-21@6 (02/01/2022)

10-2021-12@4 (04/10/2022)

NDC:

05446-0790-10

Quantity: 353 jars

Product: Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, Spearmint-Peppermint, 30g jar

Variants: Multiple Dose Container, Topical Oral Use

Lot Numbers:

08-2021-16@12 (02/01/2022)

09-2021-13@8 (02/01/2022)

09-2021-29@8 (03/01/2022)

10-2021-26@7 (04/24/2022)

NDC:

05446-0407-10

Quantity: 221 jars

Product: Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, Raspberry-Marshmallow, jar

Variants: Multiple Dose Container, Topical Oral Use

Lot Numbers:

06-2021-29@15 (12/26/2021)

07-2021-12@7 (01/08/2022)

08-2021-03@7 (01/30/2022)

08-2021-25@5 (02/01/2022)

09-2021-10@4 (02/01/2022)

09-2021-22@6 (03/01/2022)

10-2021-06@11 (04/04/2022)

NDC:

05446-1018-10

Quantity: 418 jars

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89172

Status: Resolved

Manufacturer: Edge Pharma, LLC

Sold By: hospitals; clinics; physician offices

Manufactured In: United States

Distributed To: Nationwide

Agency Last Updated: January 31, 2022