PlainRecalls
FDA Drug Critical Class I Terminated

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.

Reported: June 1, 2016 Initiated: January 21, 2016 #D-0863-2016

Product Description

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.

Reason for Recall

Presence of Particulate Matter: identified as a cloth fiber.

Details

Recalling Firm
Baxter Healthcare Corp.
Units Affected
334,560 bags
Distribution
Nationwide and Puerto Rico
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Baxter Healthcare Corp.. Units affected: 334,560 bags.
Why was this product recalled?
Presence of Particulate Matter: identified as a cloth fiber.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 1, 2016. Severity: Critical. Recall number: D-0863-2016.