Skip to content
Recall Observatory FDA recall evidence

Drug product

Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183

D-1052-2013

August 23, 2013

Class II

Product summary

Firm
Medaus, Inc.
Event
Event 66172
Status
Terminated
Classification
Class II
Quantity
2970 mL
Official record key
drug-enforcement:D-1052-2013

Official wording

Reason: 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.

Code information: LOT # 130531-31, Exp 11/27/2013

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial contamination
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility