Recalls / Class I
Class ID-0863-2016
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.
- Brand name
- Metronidazole
- Generic name
- Metronidazole
- Active ingredient
- Metronidazole
- Route
- Intravenous
- NDC
- 0338-1055
- FDA application
- NDA018657
- Affected lot / code info
- Lot #: P339135, Exp 08/31/2017
Why it was recalled
Presence of Particulate Matter: identified as a cloth fiber.
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 334,560 bags
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-01-21
- FDA classified
- 2016-05-23
- Posted by FDA
- 2016-06-01
- Terminated
- 2018-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0863-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.