March 2019 FDA Recall Drug by Akorn, Inc.
D-1080-2019 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Akorn, Inc. on March 28, 2019 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in AR and MS and the recall is currently terminated.

Recall Number: D-1080-2019

Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Initiated
03-28-2019
Reported
04-10-2019
Quantity
2,796 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82510
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.
AR and MS
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2020
Product Description About Product Description
Full technical description of the product.
Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16

Batch or Lot Expiration Information

Lot# : 356527, Exp 3/19