FDAFDA · Food and drugs·Recall number D-0515-2019
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.
Published February 27, 2019 · Recall initiated: January 25, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn Inc
- Distributor
- Nationwide, including Puerto Rico.
- Lot
- a) 357052, exp 4/19/19 b) 356892, exp 4/16/19 and 356927, exp 4/15/19
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.