Status
Terminated
Drug Enforcement D-1032-2013
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
Classification
Class II
Report Date
September 18, 2013
Termination Date
June 3, 2014
Product Information
- Product description
- Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627
- Product quantity
- 2687 Vials
- Reason for recall
- Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Wellness Pharmacy, Inc.
- Address
-
3401 Independence Drive Suite 231, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1032-2013
- Event ID
- 66188
- Recall initiation date
- August 23, 2013
- Center classification date
- September 12, 2013
- Code info
- Lot# 130612@49, Use By: 12/9/2013
- More code info
- —