FDA recall D-0426-2018

Product

Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10

Reason for recall

Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2018-01-16

Report date

2018-02-07

Termination date

2019-09-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0426-2018