🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: March 17, 2015 Akorn Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Akorn, Inc.
Reason for Recall:
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0996-2015

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