January 2019 FDA Recall Drug by Akorn Inc (D-0515-2019 - Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.)

This Class III drug recall was voluntarily initiated by Akorn Inc on January 25, 2019 for the product Drug. The FDA reported the reason for recall as failed stability specification; out of specification (oos) results for a preservative at 9 month stability study.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0515-2019

Reason for Recall
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Initiated
01-25-2019
Reported
02-27-2019
Quantity
a) 4896 tubes; b) 5064 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82092
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Akorn Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-03-2020
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# a) 357052, exp 4/19/19 b) 356892, exp 4/16/19 and 356927, exp 4/15/19