Drug product
Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
D-1038-2013
Product summary
- Event
- Event 66103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56 vials
- Official record key
drug-enforcement:D-1038-2013
Official wording
Reason: Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Code information: Lot 06072013@49, Exp 9/5/13
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
bacterial contamination
-
Sterility assurance
Lack of Assurance of Sterility