Drug product
Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.
D-0515-2019
Product summary
- Firm
- Akorn Inc
- Event
- Event 82092
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 4896 tubes; b) 5064 tubes
- Official record key
drug-enforcement:D-0515-2019
Official wording
Reason: Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Code information: a) 357052, exp 4/19/19 b) 356892, exp 4/16/19 and 356927, exp 4/15/19
Distribution pattern: Nationwide, including Puerto Rico.
Derived failure modes
-
Potency or specification failure
out of specification