FDAClass IIMay 20, 2015

Sulfamethoxazole and Trimethoprim Oral Suspension recall: Failed Dissolution

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…

Why was Sulfamethoxazole and Trimethoprim Oral Suspension recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Akorn, Inc.
Quantity
326,666 bottles (16 fl. oz. each)
Distribution
Nationwide and Puerto Rico
Recall date
May 20, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls