FDA Drug Recalls

Recalls / Class II

Class IID-0735-2022

Product

TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 127492, APS Pharmacy

Affected lot / code info
Lot: 746269 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
17 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-0735-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls