D-0515-2019 Class III Terminated
FDA drug recall D-0515-2019 was initiated by Akorn Inc on January 25, 2019 and is designated Class III. Reason for recall: Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study. The recall status is terminated (terminated November 3, 2020). Affected quantity: a) 4896 tubes; b) 5064 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- February 27, 2019
- Initiation Date
- January 25, 2019
- Termination Date
- November 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 4896 tubes; b) 5064 tubes
Product Description
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.
Reason for Recall
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Distribution Pattern
Nationwide, including Puerto Rico.
Code Information
a) 357052, exp 4/19/19 b) 356892, exp 4/16/19 and 356927, exp 4/15/19