D-0696-2017 Class II Terminated

Recalled by Akorn Inc — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
May 10, 2017
Initiation Date
March 13, 2017
Termination Date
July 9, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
55,968 bottles

Product Description

Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

Nationwide

Code Information

Lot# 348913, Exp.01/18; Lot# 349552, Exp.03/18; Lot# 349681, Exp. 03/18; Lot# 349683, Exp. 03/18; Lot# 349685, Exp. 03/18; Lot# 349687, Exp. 03/18; Lot# 349689, Exp. 03/18; Lot# 350636, Exp.03/18