Drug product
Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in a) 7.2 mL. b) 9.6 mL, c) 10.8mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
D-1471-2019
Product summary
- Event
- Event 83253
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 14.4 mL, b) 9.6 mL, c) 10.8 mL
- Official record key
drug-enforcement:D-1471-2019
Official wording
Reason: Lack of Assurance of Sterility.
Code information: Lot #: a) 05032019@18, Exp. 08/04/2019; b) 05062019@20, Exp. 08/06/2019; c) 05132019@1, Exp. 08/13/2019.
Distribution pattern: ID, WA only
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility