🔍 RecallPedia

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

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

What Should You Do?

  1. Check if you have this product:
    Lot # 623940, Exp. 10/2015; Lot # 624487, Exp. 11/2015; Lot # 624741, Exp. 11/2015; Lot # 625296, Exp. 1/2016
  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, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0995-2015

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