Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-...
FDA Recall #D-0152-2017 — Class II — November 14, 2016
Product Description
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.
Recalling Firm
Akorn Inc — Lake Forest, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
a) 62 tubes and b) 91 tubes
Distribution
Nationwide
Code Information
Lot #348716 (exp. 12/2017)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated