Drug product
Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
D-0661-2022
Product summary
- Event
- Event 89773
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 vials
- Official record key
drug-enforcement:D-0661-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #:07232020@1 BUD: 9/6/2020; 07282020@1 BUD: 9/11/2020; 07282020@2 BUD: 9/11/2020
Distribution pattern: NC only
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility