Recalls / Class III
Class IIID-0515-2019
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.
- Affected lot / code info
- a) 357052, exp 4/19/19 b) 356892, exp 4/16/19 and 356927, exp 4/15/19
Why it was recalled
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Recalling firm
- Firm
- Akorn Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- a) 4896 tubes; b) 5064 tubes
- Distribution pattern
- Nationwide, including Puerto Rico.
Timeline
- Recall initiated
- 2019-01-25
- FDA classified
- 2019-02-20
- Posted by FDA
- 2019-02-27
- Terminated
- 2020-11-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0515-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.