Medications & Supplements/Prescription Drugs

Pine Pharmaceuticals Injectable and Ophthalmic Drugs Recalled for Sterility Issues

Agency Publication Date: October 19, 2023

Summary

Pine Pharmaceuticals, LLC is voluntarily recalling 30,663 units of various compounded injectable and ophthalmic drugs, including Bevacizumab, Vancomycin, and Lidocaine. The recall was initiated due to a lack of assurance of sterility, meaning the medications may not be completely free of microorganisms. These products were distributed nationwide in the United States to healthcare providers, healthcare facilities, and specialty pharmacies. No injuries or illnesses have been reported to date.

Risk

Using medications that are not sterile can cause serious, life-threatening infections. For drugs injected into the eye, this can result in permanent vision loss, while intravenous injections can lead to systemic infections or sepsis.

What You Should Do

This recall affects multiple types of compounded injectable and ophthalmic (eye) drugs, including Bevacizumab, Vancomycin, Moxifloxacin, and Lidocaine, produced by Pine Pharmaceuticals, LLC.
Healthcare providers and patients should check the label of their medication for the product name and lot number to determine if it is affected. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product immediately.
If you have health concerns, contact your healthcare provider or pharmacist.
Contact Pine Pharmaceuticals, LLC at 355 Riverwalk Parkway, Tonawanda, NY 14150, or your distributor to arrange for the return of any unused medication.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

Other Action

Healthcare facility administered drug return.

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

Affected Products

Product: Bevacizumab Solution for Injection

Variants: 1.25 MG/0.05 ML, 1 mL syringes

Lot Numbers (344):

68622 (Exp. Date 10/3/2023)

68620 (Exp. Date 10/3/2023)

68632 (Exp. Date 10/4/2023)

68699 (Exp. Date 10/6/2023)

68704 (Exp. Date 10/6/2023)

68706 (Exp. Date 10/6/2023)

68726 (Exp. Date 10/7/2023)

68740 (Exp. Date 10/7/2023)

68784 (Exp. Date 10/11/2023)

68843 (Exp. Date 10/13/2023)

68861 (Exp. Date 10/13/2023)

68789 (Exp. Date 10/12/2023)

68822 (Exp. Date 10/12/2023)

68914 (Exp. Date 10/17/2023)

68952 (Exp. Date 10/18/2023)

68954 (Exp. Date 10/18/2023)

68980 (Exp. Date 10/18/2023)

69105 (Exp. Date 10/25/2023)

69731 (Exp. Date 11/7/2023)

69991 (Exp. Date 11/15/2023)

70142 (Exp. Date 11/22/2023)

70233 (Exp. Date 11/28/2023)

70297 (Exp. Date 11/30/2023)

70264 (Exp. Date 11/30/2023)

70291 (Exp. Date 11/30/2023)

70300 (Exp. Date 11/30/2023)

70355 (Exp. Date 12/5/2023)

70516 (Exp. Date 12/12/2023)

70513 (Exp. Date 12/12/2023)

70659 (Exp. Date 12/19/2023)

70664 (Exp. Date 12/19/2023)

70700 (Exp. Date 12/20/2023)

68912 (Exp. Date 10/17/2023)

69071 (Exp. Date 10/24/2023)

69725 (Exp. Date 10/31/2023)

69749 (Exp. Date 11/1/2023)

69961 (Exp. Date 11/14/2023)

70112 (Exp. Date 11/21/2023)

70228 (Exp. Date 11/28/2023)

70353 (Exp. Date 12/5/2023)

70403 (Exp. Date 12/9/2023)

70513 (Exp. Date 2/12/2023)

70569 (Exp. Date 12/14/2023)

70570 (Exp. Date 12/14/2023)

70579 (Exp. Date 12/14/2023)

70571 (Exp. Date 12/14/2023)

70572 (Exp. Date 12/14/2023)

70573 (Exp. Date 12/14/2023)

70585 (Exp. Date 12/14/2023)

70503 (Exp. Date 12/14/2023)

Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Product: Vancomycin Solution for Intraocular Injection

Variants: 1 MG/0.1 ML, 0.8 ML Single Dose Vial

Lot Numbers:

69985 (Exp. Date 11/15/2023)

Rx only

Product: Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL)

Lot Numbers:

69986 (Exp. Date 11/15/2023)

Rx only

Product: Calcium Gluconate Ophthalmic Irrigation Solution 1%

Variants: 500 mL bags

Lot Numbers:

69802 (Exp. Date 02/28/2024)

Rx only

Product: Calcium Gluconate 2.5% solution for inhalation

Variants: 5mL pre-filled syringes

Lot Numbers:

70363 (Exp. Date 03/20/2024)

Rx only

Product: Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution

Variants: 15 mL multi-use Droppers

Lot Numbers:

67008 (Exp. Date 10/04/2023)

67685 (Exp. Date 10/21/2023)

67853 (Exp. Date 10/25/2023)

69967 (Exp. Date 01/13/2024)

Rx only

Product: Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection

Variants: 600 mcg/0.4mL (150 mcg/0.1mL) Syringe

Lot Numbers:

67480 (Exp. Date 10/9/2023)

68640 (Exp. Date 12/3/2023)

68769 (Exp. Date 12/9/2023)

68760 (Exp. Date 12/10/2023)

68925 (Exp. Date 12/16/2023)

70119 (Exp. Date 1/20/2024)

Rx only

Product: Cefuroxime 4mg /0.4 mL (10 mg/mL)

Variants: 1mL syringe

Lot Numbers:

67918 (Exp. Date 10/29/2023)

68033 (Exp. Date 11/4/2023)

68515 (Exp. Date 11/26/2023)

68528 (Exp. Date 11/27/2023)

68618 (Exp. Date 12/2/2023)

68651 (Exp. Date 12/3/2023)

68767 (Exp. Date 12/9/2023)

68829 (Exp. Date 12/11/2023)

69820 (Exp. Date 1/9/2024)

70733 (Exp. Date 2/19/2024)

71068 (Exp. Date 3/9/2024)

67345 (Exp. Date 10/3/2023)

Rx only

Product: Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL

Variants: (100 mcg/0.1 mL) 1 mL syringes

Lot Numbers:

67623 (Exp. Date 10/15/2023)

67919 (Exp. Date 10/29/2023)

68917 (Exp. Date 12/16/2023)

69079 (Exp. Date 12/23/2023)

69120 (Exp. Date 12/24/2023)

Rx only

Product: Lidocaine-phenylephrine 1%-1.5%

Variants: 1mL Single Dose Vial

Lot Numbers:

67849 (Exp. Date 10/25/2023)

67887 (Exp. Date 10/28/2023)

68260 (Exp. Date 11/14/2023)

68534 (Exp. Date 11/27/2023)

68816 (Exp. Date 12/12/2023)

69046 (Exp. Date 12/20/2023)

69971 (Exp. Date 1/13/2024)

Rx only

Product: TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1%)

Variants: 5 mL droppers

Lot Numbers:

68184 (Exp. Date 10/9/2023)

68623 (Exp. Date 11/2/2023)

Rx only

Product: Calcium chloride Solution for Intravenous Injection

Variants: 20 mg/mL, 500 mL bags

Lot Numbers:

70101 (Exp. Date 1/17/2024)

Rx only

Product: Lidocaine HCl 4% ophthalmic solution

Variants: 3 mL single-use dropper

Lot Numbers:

67443 (Exp. Date 10/8/2023)

68775 (Exp. Date 12/9/2023)

Rx only

Product: Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution

Variants: 5mL multi-use dropper

Lot Numbers:

67659 (Exp. Date 10/16/2023)

70316 (Exp. Date 1/30/2024)

Rx only

Product: Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution

Variants: 2 mL syringes, intranasal

Lot Numbers:

67808 (Exp. Date 10/23/2023)

Rx only

Product: Foscarnet Sodium 2.4mg/0.1 mL solution for injection

Variants: 0.2 mL single-dose Staclear Luer Slip Syringe

Lot Numbers:

68680 (Exp. Date 12/4/2023)

Rx only

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93154

Status: Resolved

Manufacturer: Pine Pharmaceuticals, LLC

Sold By: Healthcare providers; Healthcare facilities; Specialty pharmacies

Manufactured In: United States

Units Affected: 16 products (2862 Syringes; 26 vials; 201 kits; 128 bags; 881 pre-filled syringes; 2181 droppers; 2484 syringes; 4972 syringes; 2176 syringes; 9673 vials; 1693 droppers; 130; 1598 droppers; 662 dropper; 860 syringes; 136 syringes)

Distributed To: Nationwide

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 multiple types of compounded injectable and ophthalmic (eye) drugs, including Bevacizumab, Vancomycin, Moxifloxacin, and Lidocaine, produced by Pine Pharmaceuticals, LLC.

Healthcare providers and patients should check the label of their medication for the product name and lot number to determine if it is affected. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product immediately.

If you have health concerns, contact your healthcare provider or pharmacist.

Contact Pine Pharmaceuticals, LLC at 355 Riverwalk Parkway, Tonawanda, NY 14150, or your distributor to arrange for the return of any unused medication.

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

Affected Products

Product: Bevacizumab Solution for Injection

Variants: 1.25 MG/0.05 ML, 1 mL syringes

Lot Numbers (344):

68622 (Exp. Date 10/3/2023)

68620 (Exp. Date 10/3/2023)

68632 (Exp. Date 10/4/2023)

68699 (Exp. Date 10/6/2023)

68704 (Exp. Date 10/6/2023)

68706 (Exp. Date 10/6/2023)

68726 (Exp. Date 10/7/2023)

68740 (Exp. Date 10/7/2023)

68784 (Exp. Date 10/11/2023)

68843 (Exp. Date 10/13/2023)

68861 (Exp. Date 10/13/2023)

68789 (Exp. Date 10/12/2023)

68822 (Exp. Date 10/12/2023)

68914 (Exp. Date 10/17/2023)

68952 (Exp. Date 10/18/2023)

68954 (Exp. Date 10/18/2023)

68980 (Exp. Date 10/18/2023)

69105 (Exp. Date 10/25/2023)

69731 (Exp. Date 11/7/2023)

69991 (Exp. Date 11/15/2023)

70142 (Exp. Date 11/22/2023)

70233 (Exp. Date 11/28/2023)

70297 (Exp. Date 11/30/2023)

70264 (Exp. Date 11/30/2023)

70291 (Exp. Date 11/30/2023)

70300 (Exp. Date 11/30/2023)

70355 (Exp. Date 12/5/2023)

70516 (Exp. Date 12/12/2023)

70513 (Exp. Date 12/12/2023)

70659 (Exp. Date 12/19/2023)

70664 (Exp. Date 12/19/2023)

70700 (Exp. Date 12/20/2023)

68912 (Exp. Date 10/17/2023)

69071 (Exp. Date 10/24/2023)

69725 (Exp. Date 10/31/2023)

69749 (Exp. Date 11/1/2023)

69961 (Exp. Date 11/14/2023)

70112 (Exp. Date 11/21/2023)

70228 (Exp. Date 11/28/2023)

70353 (Exp. Date 12/5/2023)

70403 (Exp. Date 12/9/2023)

70513 (Exp. Date 2/12/2023)

70569 (Exp. Date 12/14/2023)

70570 (Exp. Date 12/14/2023)

70579 (Exp. Date 12/14/2023)

70571 (Exp. Date 12/14/2023)

70572 (Exp. Date 12/14/2023)

70573 (Exp. Date 12/14/2023)

70585 (Exp. Date 12/14/2023)

70503 (Exp. Date 12/14/2023)

Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Product: Vancomycin Solution for Intraocular Injection

Variants: 1 MG/0.1 ML, 0.8 ML Single Dose Vial

Lot Numbers:

69985 (Exp. Date 11/15/2023)

Rx only

Product: Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL)

Lot Numbers:

69986 (Exp. Date 11/15/2023)

Rx only

Product: Calcium Gluconate Ophthalmic Irrigation Solution 1%

Variants: 500 mL bags

Lot Numbers:

69802 (Exp. Date 02/28/2024)

Rx only

Product: Calcium Gluconate 2.5% solution for inhalation

Variants: 5mL pre-filled syringes

Lot Numbers:

70363 (Exp. Date 03/20/2024)

Rx only

Product: Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution

Variants: 15 mL multi-use Droppers

Lot Numbers:

67008 (Exp. Date 10/04/2023)

67685 (Exp. Date 10/21/2023)

67853 (Exp. Date 10/25/2023)

69967 (Exp. Date 01/13/2024)

Rx only

Product: Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection

Variants: 600 mcg/0.4mL (150 mcg/0.1mL) Syringe

Lot Numbers:

67480 (Exp. Date 10/9/2023)

68640 (Exp. Date 12/3/2023)

68769 (Exp. Date 12/9/2023)

68760 (Exp. Date 12/10/2023)

68925 (Exp. Date 12/16/2023)

70119 (Exp. Date 1/20/2024)

Rx only

Product: Cefuroxime 4mg /0.4 mL (10 mg/mL)

Variants: 1mL syringe

Lot Numbers:

67918 (Exp. Date 10/29/2023)

68033 (Exp. Date 11/4/2023)

68515 (Exp. Date 11/26/2023)

68528 (Exp. Date 11/27/2023)

68618 (Exp. Date 12/2/2023)

68651 (Exp. Date 12/3/2023)

68767 (Exp. Date 12/9/2023)

68829 (Exp. Date 12/11/2023)

69820 (Exp. Date 1/9/2024)

70733 (Exp. Date 2/19/2024)

71068 (Exp. Date 3/9/2024)

67345 (Exp. Date 10/3/2023)

Rx only

Product: Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL

Variants: (100 mcg/0.1 mL) 1 mL syringes

Lot Numbers:

67623 (Exp. Date 10/15/2023)

67919 (Exp. Date 10/29/2023)

68917 (Exp. Date 12/16/2023)

69079 (Exp. Date 12/23/2023)

69120 (Exp. Date 12/24/2023)

Rx only

Product: Lidocaine-phenylephrine 1%-1.5%

Variants: 1mL Single Dose Vial

Lot Numbers:

67849 (Exp. Date 10/25/2023)

67887 (Exp. Date 10/28/2023)

68260 (Exp. Date 11/14/2023)

68534 (Exp. Date 11/27/2023)

68816 (Exp. Date 12/12/2023)

69046 (Exp. Date 12/20/2023)

69971 (Exp. Date 1/13/2024)

Rx only

Product: TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1%)

Variants: 5 mL droppers

Lot Numbers:

68184 (Exp. Date 10/9/2023)

68623 (Exp. Date 11/2/2023)

Rx only

Product: Calcium chloride Solution for Intravenous Injection

Variants: 20 mg/mL, 500 mL bags

Lot Numbers:

70101 (Exp. Date 1/17/2024)

Rx only

Product: Lidocaine HCl 4% ophthalmic solution

Variants: 3 mL single-use dropper

Lot Numbers:

67443 (Exp. Date 10/8/2023)

68775 (Exp. Date 12/9/2023)

Rx only

Product: Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution

Variants: 5mL multi-use dropper

Lot Numbers:

67659 (Exp. Date 10/16/2023)

70316 (Exp. Date 1/30/2024)

Rx only

Product: Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution

Variants: 2 mL syringes, intranasal

Lot Numbers:

67808 (Exp. Date 10/23/2023)

Rx only

Product: Foscarnet Sodium 2.4mg/0.1 mL solution for injection

Variants: 0.2 mL single-dose Staclear Luer Slip Syringe

Lot Numbers:

68680 (Exp. Date 12/4/2023)

Rx only

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93154

Status: Resolved

Manufacturer: Pine Pharmaceuticals, LLC

Sold By: Healthcare providers; Healthcare facilities; Specialty pharmacies

Manufactured In: United States

Distributed To: Nationwide