Class II
Terminated
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
- Company
- Akorn, Inc.
- Recall Initiated
- November 14, 2016
- Posted
- November 30, 2016
- Recall Number
- D-0152-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 62 tubes and b) 91 tubes
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Distribution
Nationwide
Lot / Code Info
Lot #348716 (exp. 12/2017)
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