FDA recall D-0728-2022
Drug Depot, Inc., dba APS Pharmacy · Class II · drug
Product
GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy
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-0728-2022