Status
Terminated
Drug Enforcement D-1055-2013
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Classification
Class II
Report Date
September 25, 2013
Termination Date
July 16, 2014
Product Information
- Product description
- NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183
- Product quantity
- 8750 mL
- Reason for recall
- Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Medaus, Inc.
- Address
-
6801 Cahaba Valley Rd Ste 116, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1055-2013
- Event ID
- 66172
- Recall initiation date
- August 23, 2013
- Center classification date
- September 13, 2013
- Code info
- LOT # 130613-8, Exp 12/10/2013
- More code info
- —