Recalls / Class II
Class IID-0728-2022
Product
GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy
- Affected lot / code info
- 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
Why it was recalled
Lack of sterility assurance.
Recalling firm
- Firm
- Drug Depot, Inc., dba APS Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 34911 Us Highway 19 N Ste 600, N/A, Palm Harbor, Florida 34684-1921
Distribution
- Quantity
- 6017 vials
- Distribution pattern
- Nationwide in the USA including Puerto Rico.
Timeline
- Recall initiated
- 2022-03-23
- FDA classified
- 2022-03-29
- Posted by FDA
- 2022-04-06
- Terminated
- 2023-10-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0728-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.