GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS...

FDA Drug Recall #D-0728-2022 — Class II — March 23, 2022

Recall Summary

Recall Number D-0728-2022
Classification Class II — Moderate risk
Date Initiated March 23, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Drug Depot, Inc., dba APS Pharmacy
Location Palm Harbor, FL
Product Type Drugs
Quantity 6017 vials

Product Description

GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy

Reason for Recall

Lack of sterility assurance.

Distribution Pattern

Nationwide in the USA including Puerto Rico.

Lot / Code Information

Lots: 745708 BUD: 6/21/2022; 753364 BUD: 7/27/2022; 752508 BUD: 7/24/2022; 750313 BUD: 7/16/2022; 753020 BUD: 7/26/2022; 747712 BUD: 7/4/2022; 747974 BUD: 7/5/2022; 754802 BUD: 8/3/2022; 751158 BUD: 7/19/2022; 756837 BUD: 8/16/2022; 748939 BUD: 7/10/2022; 750842 BUD: 7/18/2022; 755742 BUD: 8/8/2022; 758691 BUD: 8/28/2022; 758432 BUD: 8/27/2022; 758975 BUD: 8/29/2022; 756643 BUD: 8/15/2022

Other Recalls from Drug Depot, Inc., dba APS Pharmacy

Recall # Classification Product Date
D-0731-2022 Class II TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (1... Mar 23, 2022
D-0732-2022 Class II TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML I... Mar 23, 2022
D-0733-2022 Class II TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10... Mar 23, 2022
D-0735-2022 Class II TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML In... Mar 23, 2022
D-0734-2022 Class II TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injec... Mar 23, 2022

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.