D-206-2013 Class II Terminated
FDA drug recall D-206-2013 was initiated by Hospira Inc. on Feb 15, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal. The recall status is terminated (terminated Mar 31, 2015). Affected quantity: 567,624 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 27, 2013
- Initiation Date
- Feb 15, 2013
- Termination Date
- Mar 31, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 567,624 bags
Product Description
METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)
Reason for Recall
Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
Distribution Pattern
Nationwide.
Code Information
Lot code 12-074-JT Exp 12/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-206-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026