Status
Terminated
Drug Enforcement D-1041-2013
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.
Classification
Class II
Report Date
September 25, 2013
Termination Date
August 14, 2014
Product Information
- 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
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Leiter's Pharmacy
- Address
-
1700 Park Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1041-2013
- Event ID
- 66103
- Recall initiation date
- August 26, 2013
- Center classification date
- September 13, 2013
- Code info
- Lot # : 07302013@6 Exp 10/28/13
- More code info
- —