D-1041-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 25, 2013
- Initiation Date
- August 26, 2013
- Termination Date
- August 14, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 728 vials
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
Lot # : 07302013@6 Exp 10/28/13