FDA-Drug2019-02-27Class 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.

Akorn Inc
Hazard

Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.

Sold states
Nationwide, including Puerto Rico.
Affected count
a) 4896 tubes; b) 5064 tubes
Manufactured in
1925 W Field Ct Ste 300, Lake Forest, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0515-2019

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