Drug product
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40 mcg/25 mg/0.5mg/0.01mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0549-2
D-0933-2020
Product summary
- Event
- Event 84978
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0933-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 12042019+533225, Exp 1/17/2020
Distribution pattern: U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility