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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

Pharmcore Inc.: Sterile Injectable Drugs Recalled Due to Lack of Assurance of Sterility

Agency Publication Date: August 28, 2018
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Summary

Pharmcore Inc. is recalling 17,163 units of various injectable medications, including Human Chorionic Gonadotropin (HCG), Ipamorelin, and Methylcobalamin, due to a lack of assurance of sterility. These products are intended to be sterile, but the manufacturer cannot guarantee they are free from contamination. This recall affects multiple strengths and vial sizes of these lyophilized (freeze-dried) medications distributed nationwide. Consumers should stop using these products and contact their healthcare provider immediately, as using a non-sterile injectable product can lead to serious infections.

Risk

If an injectable drug is not sterile, it may contain bacteria or other microorganisms. Injecting a contaminated product directly into the body can cause serious or life-threatening infections, including sepsis or localized abscesses at the injection site.

What You Should Do

  1. Check your medication vials for the following products and lot numbers: Human Chorionic Gonadotropin (HCG) 5000 IU (Lots HCG50319, HCG50316, HCG50317, HCG50315, HCG50318, HCG50320, HCG50321, HCG50311, HCG50310, HCG50309, HCG50313, HCG50314); HCG 11000 IU (Lots HCG1116, HCG1117); HCG 20000 IU (Lots HCG22038, HCG22039); HCG 2500 IU (Lots HCG25112, HCG25110, HCG25115, HCG25114, HCG25111); HCG 4000 IU (Lots HCG40160, HCG40161, HCG40159, HCG40162, HCG50308); HCG 6000 IU (Lots HCG60122, HCG60124, HCG60121, HCG60123, HCG60120, HCG60118, HCG1115).
  2. Check for affected Ipamorelin or Methylcobalamin lots: Ipamorelin 3 mg (Lot IPA3-17); Ipamorelin 9 mg (Lots IPA9-15, IPA9-14); or Methylcobalamin 10 mg (Lots MTLY-19, MTLY-18).
  3. Stop using these medications immediately if the lot number on your vial matches any of the codes listed above.
  4. Contact your healthcare provider or pharmacist for guidance regarding your treatment and to report any adverse health effects.
  5. Return any unused product to the place of purchase for a refund and contact Pharmcore Inc. at 1109 E Hallandale Beach Blvd, Hallandale Beach, Florida, 33009-4431 for further instructions.
  6. For additional information or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Human Chorionic Gonadotropin 5000 IU Vial Lyophilized
Model:
D-1147-2018
Lot Numbers:
HCG50319 (Exp. 4/30/2019)
HCG50316 (Exp. 3/31/2019)
HCG50317 (Exp. 4/30/2019)
HCG50315 (Exp. 3/31/2019)
HCG50318 (Exp. 4/30/2019)
HCG50320 (Exp. 4/30/2019)
HCG50321 (Exp. 4/30/2019)
HCG50311 (Exp. 3/31/2019)
HCG50310 (Exp. 3/31/2019)
HCG50309 (Exp. 3/31/2019)
HCG50313 (Exp. 3/31/2019)
HCG50314 (Exp. 3/31/2019)
Product: Human Chorionic Gonadotropin 11000 IU Vial Lyophilized
Model:
D-1148-2018
Lot Numbers:
HCG1116 (Exp. 3/31/2019)
HCG1117 (Exp. 4/30/2019)
Product: Human Chorionic Gonadotropin 20000 IU Vial Lyophilized
Model:
D-1149-2018
Lot Numbers:
HCG22038 (Exp. 3/31/2019)
HCG22039 (Exp. 4/30/2019)
Product: Human Chorionic Gonadotropin 2500 IU Vial Lyophilized
Model:
D-1150-2018
Lot Numbers:
HCG25112 (Exp. 2/28/2019)
HCG25110 (Exp. 1/31/2019)
HCG25115 (Exp. 4/30/2019)
HCG25114 (Exp. 4/30/2019)
HCG25111 (Exp. 2/28/2019)
Product: Human Chorionic Gonadotropin 4000 IU Vial Lyophilized
Model:
D-1151-2018
Lot Numbers:
HCG40160 (Exp. 2/28/2019)
HCG40161 (Exp. 4/30/2019)
HCG40159 (Exp. 2/28/2019)
HCG40162 (Exp. 4/30/2019)
HCG50308 (Exp. 2/28/2019)
Product: Human Chorionic Gonadotropin 6000 IU Vial Lyophilized
Model:
D-1152-2018
Lot Numbers:
HCG60122 (Exp. 4/30/2019)
HCG60124 (Exp. 6/30/2019)
HCG60121 (Exp. 4/30/2019)
HCG60123 (Exp. 5/31/2019)
HCG60120 (Exp. 4/30/2019)
HCG60118 (Exp. 2/28/2019)
HCG1115 (Exp. 1/31/2019)
Product: Ipamorelin 3 mg Lyophilized 1 vial
Model:
D-1153-2018
Lot Numbers:
IPA3-17 (Exp. 07/2018)
Product: Methylcobalamin 10 mg vial Lyophilized
Model:
D-1154-2018
Lot Numbers:
MTLY-19 (Exp. 10/31/2018)
MTLY-18 (Exp. 8/31/2018)
Product: Ipamorelin 9 mg vial Lyophilized
Model:
D-1155-2018
Lot Numbers:
IPA9-15 (Exp. 3/31/2019)
IPA9-14 (Exp. 1/31/2019)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80699
Status: Resolved
Manufacturer: Pharmcore Inc.
Sold By: Pharmcore Inc.
Manufactured In: United States
Units Affected: 9 products (5718 vials; 864 vials; 355 vials; 3070 vials; 2085 vials; 3351 vials; 6 vials; 1115 vials; 599 vials)
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

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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 · 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.