Drug product
ITPP 50 mg/ml DMG 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
D-744-2013
Product summary
- Event
- Event 65360
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2
- Official record key
drug-enforcement:D-744-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: A3113 Exp 7/1/13 and A3401 Exp 2/1/14
Distribution pattern: Nationwide and PR
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility