Drug product
Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
D-0660-2022
Product summary
- Event
- Event 89773
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 vials
- Official record key
drug-enforcement:D-0660-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 07212020@ BUD: 9/4/2020
Distribution pattern: NC only
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility