FDA-Drug2016-11-30Class II

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

Akorn Inc
Hazard

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

Sold states
Nationwide
Affected count
a) 62 tubes and b) 91 tubes
Manufactured in
1925 W Field Ct, N/A, Lake Forest, IL, United States
Products
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

Official notice

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

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