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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Promise Pharmacy, LLC: Various Compounded Injectable and Ophthalmic Drugs Recalled for Sterility Issues

Agency Publication Date: February 8, 2019
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Summary

Promise Pharmacy, LLC is recalling 13,925 units of various compounded prescription drugs, including eye drops (Acetylcysteine, Prednisolone combos) and injectable medications (Vitamin D3, HCG, B-Complex), due to a lack of sterility assurance. These products were distributed nationwide in the USA through a voluntary firm-initiated recall. Because these products are intended to be sterile, a lack of sterility can lead to serious infections and health complications for patients.

Risk

The medications may not be sterile, which poses a significant risk of infection at the site of injection or within the eye. Using non-sterile ophthalmic or injectable products can result in vision loss, systemic infections, or other life-threatening medical conditions.

What You Should Do

  1. Immediately identify if you have any of the 51 recalled medications by checking the product label for the 'Promise Pharmacy' name and matching the lot numbers and Beyond Use Dates (BUD). For example, check for Acetylcysteine Ophthalmic Solution Lot 11072018 with BUD 12/22/2018, or Vitamin D3 Injection Lots 09112018@10, 09212018@9, and 11132018@10.
  2. Stop using any affected medications immediately to prevent the risk of serious infection.
  3. Contact your healthcare provider or pharmacist right away to discuss alternative treatments and to report any adverse health effects you may have experienced while using these drugs.
  4. Return any unused product to Promise Pharmacy at 31818 Us Highway 19 N, Palm Harbor, Florida, 34684-3713, or follow the instructions provided in the recall notification letter sent by the firm for a refund.
  5. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Acetylcysteine Ophthalmic Solution, 100mg/ml, 10% (10 ml)
Model:
D-0431-2019
Lot Numbers:
11072018@10 (BUD: 12/22/2018)
11072018
Date Ranges: BUD: 12/22/2018
Product: Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops (3 mL)
Model:
D-0432-2019
Lot Numbers:
10252018@8 (BUD: 2/10/2019)
10252018
Date Ranges: BUD: 2/10/2019
Product: Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops (3 mL)
Model:
D-0433-2019
Lot Numbers:
11052018@4 (BUD: 1/18/2019)
11052018
Date Ranges: BUD: 1/18/2019
Product: Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops (3 mL)
Model:
D-0434-2019
Lot Numbers:
09262018@5 (BUD: 1/15/2019)
10092018@1 (BUD: 1/25/2019)
11052018@1 (BUD: 2/21/2019)
Date Ranges: BUD: 1/15/2019, BUD: 1/25/2019, BUD: 2/21/2019
Product: Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops (6 mL)
Model:
D-0435-2019
Lot Numbers:
09192018@4 (BUD: 12/18/2018)
10112018@1 (BUD: 12/24/2018)
10262018@1 (BUD: 1/8/2019)
10302018@1 (BUD: 1/12/2019)
11082018@6 (BUD: 1/21/2019)
Date Ranges: BUD: 12/18/2018, BUD: 12/24/2018, BUD: 1/8/2019, BUD: 1/12/2019, BUD: 1/21/2019
Product: Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops (3 mL)
Model:
D-0436-2019
Lot Numbers:
11012018@1 (BUD: 1/14/2019)
11022018@1 (BUD: 1/15/2019)
Date Ranges: BUD: 1/14/2019, BUD: 1/15/2019
Product: Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops (3 mL)
Model:
D-0437-2019
Lot Numbers:
09262018@6 (BUD: 12/25/2018)
11052018@2 (BUD: 2/3/2019)
Date Ranges: BUD: 12/25/2018, BUD: 2/3/2019
Product: Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine (10 mL)
Model:
D-0438-2019
Lot Numbers:
10092018@4 (BUD: 1/7/2019)
11122018@7 (BUD: 2/10/2019)
Date Ranges: BUD: 1/7/2019, BUD: 2/10/2019
Product: Multi Trace Injection, Zinc/Copper/Manganese/Selenium (30 mL)
Model:
D-0439-2019
Lot Numbers:
10312018@5 (BUD: 12/15/2018)
10312018
Date Ranges: BUD: 12/15/2018
Product: Vitamin D3 50,000iu/mL Injection (5 mL)
Model:
D-0440-2019
Lot Numbers:
09112018@10 (BUD: 1/2/2019)
09212018@9 (BUD: 1/12/2019)
11132018@10 (BUD: 2/27/2019)
Date Ranges: BUD: 1/2/2019, BUD: 1/12/2019, BUD: 2/27/2019
Product: Trim Complete Injection (10 mL)
Model:
D-0441-2019
Lot Numbers:
10022018@6 (BUD: 12/31/2018)
10022018
Date Ranges: BUD: 12/31/2018
Product: Methylcobalamin lyophilized 50,000 mcg Injection
Model:
D-0442-2019
Lot Numbers:
08212018@11 (BUD: 12/19/2018)
10012018@1 (BUD: 1/29/2019)
Date Ranges: BUD: 12/19/2018, BUD: 1/29/2019
Product: Methylcobalamin lyophilized 10,000 mcg Injection
Model:
D-0443-2019
Lot Numbers:
08032018@3 (BUD: 01/30/2019)
08272018@6 (BUD: 2/23/2019)
09142018@4 (BUD: 3/13/2019)
10012018@3 (BUD: 3/30/2019)
Date Ranges: BUD: 01/30/2019, BUD: 2/23/2019, BUD: 3/13/2019, BUD: 3/30/2019
Product: Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine (10 mL)
Model:
D-0444-2019
Lot Numbers:
08302018@12 (BUD: 12/24/2018)
10242018@2 (BUD: 2/17/2019)
Date Ranges: BUD: 12/24/2018, BUD: 2/17/2019
Product: Glutathione Injection, 200 mg/mL (10 mL)
Model:
D-0445-2019
Lot Numbers:
09172018@7 (BUD: 12/16/2018)
10292018@2 (BUD: 1/27/2019)
Date Ranges: BUD: 12/16/2018, BUD: 1/27/2019
Product: Ascorbic Acid Injection, Compounded-Tapioca, 450 mg/mL (50 mL)
Model:
D-0446-2019
Lot Numbers:
10152018@1 (BUD: 1/13/2019)
10312018@2 (BUD: 1/29/2019)
Date Ranges: BUD: 1/13/2019, BUD: 1/29/2019
Product: Thymosin Beta-4, 15 mg Injection
Model:
D-0447-2019
Lot Numbers:
08302018@8 (BUD: 2/26/2019)
10012018@2 (BUD: 3/30/2019)
07052018@2 (BUD: 01/01/2019)
Date Ranges: BUD: 2/26/2019, BUD: 3/30/2019, BUD: 01/01/2019
Product: Sermorelin Theanine/GHRP2 Injection
Model:
D-0448-2019
Lot Numbers:
07202018@4 (BUD: 1/16/2019)
07202018
Date Ranges: BUD: 1/16/2019
Product: Sermorelin 9 mg injection
Model:
D-0449-2019
Lot Numbers:
06182018@2 (BUD: 12/15/2018)
08212018@12 (BUD: 2/17/2019)
09212018@15 (BUD: 3/20/2019)
11132018@1 (BUD: 5/12/2019)
Date Ranges: BUD: 12/15/2018, BUD: 2/17/2019, BUD: 3/20/2019, BUD: 5/12/2019
Product: Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection
Model:
D-0450-2019
Lot Numbers:
07102018@3 (BUD: 1/6/2019)
08302018@9 (BUD: 2/26/2019)
Date Ranges: BUD: 1/6/2019, BUD: 2/26/2019
Product: Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection
Model:
D-0451-2019
Lot Numbers:
08302018@13 (BUD: 2/26/2019)
09212018@14 (BUD: 3/20/2019)
Date Ranges: BUD: 2/26/2019, BUD: 3/20/2019
Product: Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection
Model:
D-0452-2019
Lot Numbers:
07052018@1 (BUD: 1/1/2019)
09182018@6 (BUD: 3/1/2019)
09212018@10 (BUD: 3/4/2019)
10052018@1 (BUD: 3/18/2019)
11062018@2 (BUD: 4/19/2019)
Date Ranges: BUD: 1/1/2019, BUD: 3/1/2019, BUD: 3/4/2019, BUD: 3/18/2019, BUD: 4/19/2019
Product: Ipamorelin, 9 mg injection
Model:
D-0453-2019
Lot Numbers:
07132018@5 (BUD: 1/9/2019)
07302018@32 (BUD: 1/26/2019)
09182018@7 (BUD: 3/17/2019)
10192018@2 (BUD: 4/17/2019)
Date Ranges: BUD: 1/9/2019, BUD: 1/26/2019, BUD: 3/17/2019, BUD: 4/17/2019
Product: Ipamorelin+Sermorelin, 15mg/15mg, injection
Model:
D-0454-2019
Lot Numbers:
09212018@12 (BUD: 12/20/2018)
11062018@3 (BUD: 6/4/2019)
Date Ranges: BUD: 12/20/2018, BUD: 6/4/2019
Product: Ipamorelin, 15mg, injection
Model:
D-0455-2019
Lot Numbers:
09182018@4 (BUD: 3/17/2019)
10052018@3 (BUD: 4/3/2019)
11132018@3 (BUD: 5/12/2019)
Date Ranges: BUD: 3/17/2019, BUD: 4/3/2019, BUD: 5/12/2019
Product: IGF-1 LR3, 620 mcg injection
Model:
D-0456-2019
Lot Numbers:
06282018@3 (BUD: 12/25/2018)
06282018
Date Ranges: BUD: 12/25/2018
Product: Epithalon, 15mg injection
Model:
D-0457-2019
Lot Numbers:
09212018@11 (BUD: 12/20/2018)
11132018@4 (BUD: 2/11/2019)
Date Ranges: BUD: 12/20/2018, BUD: 2/11/2019
Product: Bremelanotide (PT 141), 20mg injection
Model:
D-0458-2019
Lot Numbers:
10192018@4 (BUD: 12/18/2019)
11132018@5 (BUD: 1/12/2019)
Date Ranges: BUD: 12/18/2019, BUD: 1/12/2019
Product: BPC 157, 10mg injection
Model:
D-0459-2019
Lot Numbers:
11062018@5 (BUD: 2/4/2019)
11062018
Date Ranges: BUD: 2/4/2019
Product: HCG, Human chorionic gonadotropin 11,000 units, injection
Model:
D-0460-2019
Lot Numbers:
06182018@5 (BUD: 12/15/2018)
07102018@5 (BUD: 1/6/2018)
08212018@8 (BUD: 2/17/2019)
Date Ranges: BUD: 12/15/2018, BUD: 1/6/2018, BUD: 2/17/2019
Product: HCG, Human chorionic gonadotropin 5,000 units, injection
Model:
D-0461-2019
Lot Numbers:
06252018@1 (BUD: 12/22/2018)
07132018@7 (BUD: 1/9/2019)
07262018@2 (BUD: 1/22/2019)
08212018@7 (BUD: 2/17/2019)
08272018@2 (BUD: 2/23/2019)
09052018@2 (BUD: 2/28/2019)
Date Ranges: BUD: 12/22/2018, BUD: 1/9/2019, BUD: 1/22/2019, BUD: 2/17/2019, BUD: 2/23/2019, BUD: 2/28/2019
Product: HCG, Human chorionic gonadotropin 2,000 units, injection
Model:
D-0462-2019
Lot Numbers:
07172018@15 (BUD: 1/13/2019)
08272018@3 (BUD: 2/23/2019)
Date Ranges: BUD: 1/13/2019, BUD: 2/23/2019
Product: Sermorelin, 15mg, injection
Model:
D-0463-2019
Lot Numbers:
07102018@4 (BUD: 1/6/2019)
09142018@6 (BUD: 3/13/2019)
10052018@4 (BUD: 4/3/2019)
11062018@1 (BUD: 5/5/2019)
Date Ranges: BUD: 1/6/2019, BUD: 3/13/2019, BUD: 4/3/2019, BUD: 5/5/2019
Product: IGF-1-LR3, 3 mg injection
Model:
D-0464-2019
Lot Numbers:
06282018@2 (BUD: 12/25/2018)
06282018
Date Ranges: BUD: 12/25/2018
Product: Melanotan II, 10mg injection
Model:
D-0465-2019
Lot Numbers:
07202018@3 (BUD: 1/13/2019)
09212018@13 (BUD: 2/28/2019)
Date Ranges: BUD: 1/13/2019, BUD: 2/28/2019
Product: ICB-Complex, injection (10ml)
Model:
D-0466-2019
Lot Numbers:
09262018@1 (BUD: 12/25/2018)
10232018@5 (BUD: 1/21/2019)
11012018@3 (BUD: 1/30/2019)
Date Ranges: BUD: 12/25/2018, BUD: 1/21/2019, BUD: 1/30/2019
Product: MIC B12+L-Carnitine+Chromium injection (10mL)
Model:
D-0467-2019
Lot Numbers:
10102018@1 (BUD: 1/8/2019)
10102018
Date Ranges: BUD: 1/8/2019
Product: Nicotinamide Adenine Dinucleotide, 0.5 mg, injection (10mL)
Model:
D-0468-2019
Lot Numbers:
11062018@13 (BUD: 12/21/2018)
11072018@24 (BUD: 12/22/2018)
Date Ranges: BUD: 12/21/2018, BUD: 12/22/2018
Product: Niacinamide injection, 100mg/mL (5mL)
Model:
D-0469-2019
Lot Numbers:
11022018@9 (BUD: 12/17/2018)
11022018
Date Ranges: BUD: 12/17/2018
Product: Myer's Cocktail injection (10ml)
Model:
D-0470-2019
Lot Numbers:
11072018@2 (BUD: 12/14/2018)
11072018
Date Ranges: BUD: 12/14/2018
Product: Zinc Sulfate, 5mg/mL injection (10ml)
Model:
D-0471-2019
Lot Numbers:
11132018@9 (BUD: 12/28/2018)
Date Ranges: BUD: 12/28/2018
Product: Folic Acid, Injection, 10 mg/mL (10mL)
Model:
D-0472-2019
Lot Numbers:
11022018@4 (BUD: 12/17/2018)
Date Ranges: BUD: 12/17/2018
Product: Trim Calm Injection (10mL)
Model:
D-0473-2019
Lot Numbers:
11052018@7 (BUD: 12/20/2018)
11052018
Date Ranges: BUD: 12/20/2018
Product: Procaine HCl, 2% injection (10ml)
Model:
D-0474-2019
Lot Numbers:
11082018@4 (BUD: 12/23/2018)
10302018@4 (BUD: 12/14/2018)
Date Ranges: BUD: 12/23/2018, BUD: 12/14/2018
Product: Pyridoxine HCl, 100 mg/mL Injection (10ml)
Model:
D-0475-2019
Lot Numbers:
10302018@3 (BUD: 12/14/2018)
10302018
Date Ranges: BUD: 12/14/2018
Product: Leucine/Isoleucine/Valine injection (10mL)
Model:
D-0476-2019
Lot Numbers:
10312018@3 (BUD: 12/15/2018)
10312018
Date Ranges: BUD: 12/15/2018
Product: Lysine HCl, 100 mg/mL injection (10ml)
Model:
D-0477-2019
Lot Numbers:
11132018@8 (BUD: 12/28/2018)
11132018
Date Ranges: BUD: 12/28/2018
Product: Dexpanthenol, 250mg/mL Injection (10ml)
Model:
D-0478-2019
Lot Numbers:
11052018@5 (BUD: 12/20/2018)
11052018
Date Ranges: BUD: 12/20/2018
Product: Glycyrrhizic Acid, 8mg/mL Injection (10ml)
Model:
D-0479-2019
Lot Numbers:
11052018@6 (BUD: 12/20/2018)
11052018
Date Ranges: BUD: 12/20/2018
Product: Zinc Sulfate, 10mg/ml injection (10ml)
Model:
D-0480-2019
Lot Numbers:
10302018@7 (BUD: 12/14/2018)
10302018
Date Ranges: BUD: 12/14/2018
Product: Folic Acid, 5mg/ml injection (10ml)
Model:
D-0481-2019
Lot Numbers:
10302018@8 (BUD: 12/14/2018)
10302018
Date Ranges: BUD: 12/14/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81810
Status: Resolved
Manufacturer: Promise Pharmacy, LLC
Sold By: Promise Pharmacy; Compounding Specialists
Manufactured In: United States
Units Affected: 51 products (75 10 ml bottles; 43 3 mL bottles; 55 3 ml bottles; 250 3 ml bottles; 2057 6 ml bottles; 900 3 ml bottles; 167 3 ml bottles; 204 10 ml vials; 3 30 ml vials; 210 5 ml vials; 158 10 ml vials; 252 vials; 704 vials; 158 10 ml vials; 288 10 ml vials; 196 50 ml vials; 94 vials; 25 vials; 255 vials; 341 vials; 296 vials; 927 vials; 416 vials; 139 vials; 93 vials; 59 vials; 30 vials; 64 vials; 37 vials; 654 vials; 2595 vials; 819 vials; 266 vials; 59 vials; 43 vials; 846 vials; 64 vials; 5 10 mL vials; 1 vial; 5 vials; 2 10 ml vials; 5 10ml vials; 7 10 ml vials; 11 10ml vials; 8 10ml vials; 15 10ml vials; 11 10 ml vials; 7 vials; 2 10ml vials; 3; 1 10 ml vial)
Distributed To: Nationwide

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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 ยท 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.