FDA recall D-0863-2016

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.

Reason for recall

Presence of Particulate Matter: identified as a cloth fiber.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-01-21

Report date

2016-06-01

Termination date

2018-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0863-2016