D-1052-2013 Class II Terminated
FDA drug recall D-1052-2013 was initiated by Medaus, Inc. on Aug 23, 2013 and is designated Class II. 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 recall status is terminated (terminated Jul 16, 2014). Affected quantity: 2970 mL.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 25, 2013
- Initiation Date
- Aug 23, 2013
- Termination Date
- Jul 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2970 mL
Product Description
Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183
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.
Distribution Pattern
Nationwide
Code Information
LOT # 130531-31, Exp 11/27/2013
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1052-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026