Drug product
Alprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL
D-695-2013
Product summary
- Event
- Event 65360
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5
- Official record key
drug-enforcement:D-695-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: B5008 exp 12/31/13, K5030 Exp. 11/30/13, A5716 Exp. 8/31/13, C5121 Exp 9/12/13, and C5208 Exp 9/7/13
Distribution pattern: Nationwide and PR
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility