Product Detail

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

Recall Number D-1041-2013

Classification Class II

Code Info Lot # : 07302013@6 Exp 10/28/13

Product Distributed Qty 728 vials

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.

Event Detail

Event Id 66103

Product Type Drugs

Status Ongoing

Recalling Firm

Leiter's Pharmacy
City San Jose

State CA
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-08-26

Initial Firm Notification of Consignee or Public Two or more of the following: Email,
Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide