Home / Recalls / Akorn, Inc. / D-0996-2015

D-0996-2015 Class II Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

FDA drug recall D-0996-2015 was initiated by Akorn, Inc. on Mar 17, 2015 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. The recall status is terminated (terminated Dec 27, 2017). Affected quantity: 326,666 bottles (16 fl. oz. each).

Recall Details

Product Type
Drugs
Report Date
May 20, 2015
Initiation Date
Mar 17, 2015
Termination Date
Dec 27, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
326,666 bottles (16 fl. oz. each)

Product Description

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

Reason for Recall

Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

Distribution Pattern

Nationwide and Puerto Rico

Code 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

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0996-2015
openFDA file date
Oct 27, 2026
Loaded by RegDataLab
Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources