Drug product
Bi mix, compounded by Olympia Pharmacy, Orlando, FL
D-706-2013
Product summary
- Event
- Event 65360
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4
- Official record key
drug-enforcement:D-706-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: A5028 Exp 6/2/13, B5011 exp 6/1/13, C4112 Exp 6/1/13, and C4208 Exp 6/20/13
Distribution pattern: Nationwide and PR
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility