Recalls / Class II
Class IID-0730-2022
Product
TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b) (RM) 10 ML Formula ID 115125; APS Pharmacy
- Affected lot / code info
- Lots: a) 745383 BUD: 6/20/2022; 759295 BUD: 8/30/2022; b) 745749 BUD: 6/21/2022; 746272 BUD: 6/27/2022
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
- 846 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-0730-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.