FDA Recall Terminated Historical recordClass III
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
- Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
- Published
- February 27, 2019
- Distribution
- Nationwide
