Recalls / Class II
Class IID-0480-2017
Product
METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24
- Affected lot / code info
- Lot: 54-054-JT, 6/1/2017
Why it was recalled
Lack of Sterility Assurance: customer report of leaking bag
Recalling firm
- Firm
- Hospira Inc., A Pfizer Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 578,784 bags
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2017-02-10
- FDA classified
- 2017-02-17
- Posted by FDA
- 2017-03-01
- Terminated
- 2019-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0480-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.