November 2016 FDA Recall Drug by Akorn Inc
D-0152-2017 - Failed Stability Specifications; out-of specification value for homogeneity / phase separation.

This Class II drug recall was voluntarily initiated by Akorn Inc on November 14, 2016 for the product Drug. The FDA reported the reason for recall as failed stability specifications; out-of specification value for homogeneity / phase separation.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0152-2017

Reason for Recall
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Initiated
11-14-2016
Reported
11-30-2016
Quantity
a) 62 tubes and b) 91 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75628
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-10-2019
Product Description About Product Description
Full technical description of the product.
Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY

Batch or Lot Expiration Information

Lot# 348716 (exp. 12/2017)