FDA recall D-0731-2022

Drug Depot, Inc., dba APS Pharmacy · Class II · drug

Product

TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged in a multi dose 10ML vial, as a) (CA) 4 ML Formula ID 136164; b) (RM) 10 ML Formula ID 115962; APS Phar

Reason for recall

Lack of sterility assurance.

Distribution

Nationwide in the USA including Puerto Rico.

Key facts

Status: Terminated
Initiation date: 2022-03-23
Report date: 2022-04-06
Termination date: 2023-10-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Palm Harbor, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0731-2022