Class III
Terminated
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.
This recall has been terminated (originally issued February 27, 2019).
- Company
- Akorn, Inc.
- Recall Initiated
- January 25, 2019
- Posted
- February 27, 2019
- Recall Number
- D-0515-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 4896 tubes; b) 5064 tubes
- Firm Location
- Lake Forest, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Distribution
Nationwide, including Puerto Rico.
Lot / Code Info
a) 357052, exp 4/19/19 b) 356892, exp 4/16/19 and 356927, exp 4/15/19
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