Recalls / Class II
Class IID-0729-2022
Product
(CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy
- Affected lot / code info
- Lots: 749842 BUD: 7/13/2022; 749568 BUD: 7/12/2022; 752053 BUD: 7/23/2022; 752817 BUD: 7/25/2022; 757404 BUD: 8/21/2022; 757915 BUD: 8/23/2022; 757321 BUD: 8/20/2022; 753718 BUD: 7/30/2022
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
- 1843 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-0729-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.