Recalls / Class II
Class IID-206-2013
Product
METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)
- Affected lot / code info
- Lot code 12-074-JT Exp 12/13
Why it was recalled
Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 567,624 bags
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2013-02-15
- FDA classified
- 2013-03-21
- Posted by FDA
- 2013-03-27
- Terminated
- 2015-03-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-206-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.