Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only...

FDA Drug Recall #D-0917-2017 - Class I, December 29, 2015

Recall Summary

Recall Number D-0917-2017
Classification Class I - Serious risk
Date Initiated December 29, 2015
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Complete Pharmacy and Medical Solutions LLC
Location Miami Lakes, FL
Product Type Drugs
Quantity 1890 syringes

Product Description

Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014

Reason for Recall

Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.

Distribution Pattern

Distributed throughout Florida

Lot / Code Information

Lot # 2079ps5, Exp 02/01/2016

Other Recalls from Complete Pharmacy and Medical Solutio...

Recall # Classification Product Date
D-0918-2017 Class I Human Chorionic Gonadotropin, 15,000 IU per via... Apr 2, 2016

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.