Recalls / Class II
Class IID-0732-2022
Product
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy
- Affected lot / code info
- Lots: a)746000 BUD: 6/26/2022; b) 751472 BUD: 7/20/2022
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
- 620 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-0732-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.