FDA recall D-0152-2017

Akorn Inc · Class II · drug

Product

Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY

Reason for recall

Failed Stability Specifications; out-of specification value for homogeneity / phase separation.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2016-11-14
Report date: 2016-11-30
Termination date: 2019-05-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0152-2017