Recalls / Class II
Class IID-1052-2013
Product
Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183
- Affected lot / code info
- LOT # 130531-31, Exp 11/27/2013
Why it was recalled
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.
Recalling firm
- Firm
- Medaus, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 6801 Cahaba Valley Rd Ste 116, N/A, Birmingham, Alabama 35242-9609
Distribution
- Quantity
- 2970 mL
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-08-23
- FDA classified
- 2013-09-13
- Posted by FDA
- 2013-09-25
- Terminated
- 2014-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1052-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.