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
D-0152-2017
Product summary
- Firm
- Akorn Inc
- Event
- Event 75628
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 62 tubes and b) 91 tubes
- Official record key
drug-enforcement:D-0152-2017
Official wording
Reason: Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Code information: Lot #348716 (exp. 12/2017)
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out-of specification