Baxter Healthcare Corp. recalls Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA,…

Recall date

January 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0863-2016

FDA classification

Class I

Brand / firm

Baxter Healthcare Corp.

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Presence of Particulate Matter: identified as a cloth fiber.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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.