Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale...

FDA Drug Recall #D-1150-2018 — Class II — August 2, 2018

Recall Summary

Recall Number D-1150-2018
Classification Class II — Moderate risk
Date Initiated August 2, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Pharmcore Inc.
Location Hallandale Beach, FL
Product Type Drugs
Quantity 3070 vials

Product Description

Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009

Reason for Recall

Lack of assurance of sterility.

Distribution Pattern

Nationwide

Lot / Code Information

Lots: 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

Other Recalls from Pharmcore Inc.

Recall # Classification Product Date
D-1153-2018 Class II Ipamorelin 3 mg Lyophilized 1 vial 1109 East Ha... Aug 2, 2018
D-1152-2018 Class II Human Chorionic Gonadotropin 6000 IU Vial Lyoph... Aug 2, 2018
D-1149-2018 Class II Human Chorionic Gonadotropin 20000 IU Vial Lyop... Aug 2, 2018
D-1154-2018 Class II Methylcobalamin 10 mg vial Lyophilized 1109 Eas... Aug 2, 2018
D-1147-2018 Class II Human Chorionic Gonadotropin 5000 IU Vial Lyoph... Aug 2, 2018

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.