FDA recall D-0231-2016

Product

RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.

Reason for recall

Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.

Distribution

US: Nationwide

Key facts

Status

Terminated

Initiation date

2015-08-20

Report date

2015-11-25

Termination date

2017-01-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0231-2016