FDA recall D-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.

Reason for recall

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

Distribution

Nationwide, including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2019-01-25

Report date

2019-02-27

Termination date

2020-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

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