FDA recall D-1469-2016

Product

Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.

Reason for recall

Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-07-27

Report date

2016-08-31

Termination date

2017-07-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1469-2016