Drug product
Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
D-1041-2013
Product summary
- Event
- Event 66103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 728 vials
- Official record key
drug-enforcement:D-1041-2013
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/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured.
Code information: Lot # : 07302013@6 Exp 10/28/13
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
bacterial contamination
-
Sterility assurance
Lack of Assurance of Sterility