Status
Terminated
Drug Enforcement D-206-2013
Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
Classification
Class II
Report Date
March 27, 2013
Termination Date
March 31, 2015
Product Information
- 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)
- Product quantity
- 567,624 bags
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide.
Location & Firm
- Recalling firm
- Hospira Inc.
- Address
-
275 N Field Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-206-2013
- Event ID
- 64482
- Recall initiation date
- February 15, 2013
- Center classification date
- March 21, 2013
- Code info
- Lot code 12-074-JT Exp 12/13
- More code info
- —