Multi-event March 2015 FDA Recall Drug by Akorn, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Akorn, Inc. on March 17, 2015 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0997-2015 TERMINATED D-0995-2015 TERMINATED D-0996-2015 TERMINATED

Recall Number: D-0997-2015

Reason for Recall
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Initiated
03-17-2015
Reported
05-20-2015
Quantity
8,400 unit dose cups (20 mL each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70743
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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-27-2017
Product Description About Product Description
Full technical description of the product.
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

Batch or Lot Expiration Information

Lot# 624271, Exp. Date 10/2015

Recall Number: D-0995-2015

Reason for Recall
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Initiated
03-17-2015
Reported
05-20-2015
Quantity
27,648 bottles (16 fl. oz. each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70743
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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-27-2017
Product Description About Product Description
Full technical description of the product.
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

Batch or Lot Expiration Information

Lot# 623940, Exp. 10/2015
Lot# 624487, Exp. 11/2015
Lot# 624741, Exp. 11/2015
Lot# 625296, Exp. 1/2016

Recall Number: D-0996-2015

Reason for Recall
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Initiated
03-17-2015
Reported
05-20-2015
Quantity
326,666 bottles (16 fl. oz. each)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70743
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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-27-2017
Product Description About Product Description
Full technical description of the product.
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

Batch or Lot Expiration Information

Lot# 618358, Exp. 11/15/2015
Lot# 618646, Exp. 11/18/2015
Lot# 618649, Exp. 11/19/2015
Lot# 618652, Exp. 11/20/2015
Lot# 618746, Exp. 11/26/2015
Lot# 618749, Exp. 11/27/2015
Lot# 618934, Exp. 12/5/2015
Lot# 618940, Exp. 12/6/2015
Lot# 618946, Exp. 12/8/2015
Lot# 621496, Exp. 5/13/2016
Lot# 621890, Exp. 6/24/2016
Lot# 622779, Exp. 7/27/2016
Lot# 623389, Exp. 8/31/2016
Lot# 623829, Exp. 9/27/2016
Lot# 623946, Exp. 10/2/2016
Lot# 623952, Exp. 10/3/2016
Lot# 623955, Exp. 10/3/2016
Lot# 624147, Exp. 10/8/2016
Lot# 624153, Exp. 10/9/2016
Lot# 624159, Exp. 10/15/2016
Lot# 624162, Exp. 10/17/2016
Lot# 624271, Exp. 10/18/2016
Lot# 624274, Exp. 10/18/2016
Lot# 624490, Exp. 10/23/2016
Lot# 624493, Exp. 10/23/2016
Lot# 624496, Exp. 10/25/2016
Lot# 624499, Exp. 10/25/2016
Lot# 624744, Exp. 11/6/2016
Lot# 624747, Exp. 11/6/2016
Lot# 624750, Exp. 11/8/2016
Lot# 624753, Exp. 11/8/2016
Lot# 624836, Exp. 11/14/2016
Lot# 624839, Exp. 11/15/2016
Lot# 625120, Exp. 12/4/2016
Lot# 625123, Exp. 12/29/2016
Lot# 625126, Exp. 12/30/2016
Lot# 625795, Exp. 1/14/2017
Lot# 625918, Exp. 1/22/2017
Lot# 625921, Exp. 1/23/2017
Lot# 625924, Exp. 1/23/2017
Lot# 625927, Exp. 1/24/2017
Lot# 626211, Exp. 2/6/2017
Lot# 626465, Exp. 3/25/2017
Lot# 626735, Exp. 3/5/2017
Lot# 626743, Exp. 3/20/2017