Recalls / Class II
Class IID-1032-2013
Product
Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627
- Affected lot / code info
- Lot# 130612@49, Use By: 12/9/2013
Why it was recalled
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.
Recalling firm
- Firm
- Wellness Pharmacy, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 3401 Independence Drive Suite 231, N/A, Birmingham, Alabama 35209-8326
Distribution
- Quantity
- 2687 Vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-08-23
- FDA classified
- 2013-09-12
- Posted by FDA
- 2013-09-18
- Terminated
- 2014-06-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1032-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.