D-629-2013 Class II Terminated
FDA drug recall D-629-2013 was initiated by Baxter Healthcare Corp. on May 21, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue… The recall status is terminated (terminated Jun 18, 2015). Affected quantity: 172,296 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 10, 2013
- Initiation Date
- May 21, 2013
- Termination Date
- Jun 18, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 172,296 units
Product Description
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
Reason for Recall
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Distribution Pattern
Nationwide & Puerto Rico
Code Information
Lot #: P280123, P280123A, Exp 2/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-629-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026