FDA recall D-206-2013

Product

METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)

Reason for recall

Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2013-02-15

Report date

2013-03-27

Termination date

2015-03-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-206-2013