Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059. NDC carton: 0067-6089-01, NDC packet: 0067-6089-03

Class I - Dangerous
💊 Drugs Recalled: December 23, 2019 GSK Consumer Health Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot: K79A, K79B, K79C, exp 3/31/2021; XB2W, Y23L, Y23V, exp 5/31/2021; 19N1793000, 19N1895942, 19N1952247, 19N1884668, 19N1936498, 19N1936583, exp 3/31/2021; 19N1920630, 19N1958240, exp 4/30/2021; 19N1957675, M926001MA, M926002MA, M926003MA, M926004MA, M926005MA, M926006MA, M926007MA, M926008MA, M926009MA, M926201MA, M926202MA, exp 5/31/2021; M926201MB, M926202MB, M926203MB, M926204MB, M926205MB, M926206MB, M926207MB, M926208MB, M926209MB, exp 2/28/2021
  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:
GSK Consumer Health, Inc
Reason for Recall:
Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059. NDC carton: 0067-6089-01, NDC packet: 0067-6089-03

Product Codes/Lot Numbers:

Lot: K79A, K79B, K79C, exp 3/31/2021; XB2W, Y23L, Y23V, exp 5/31/2021; 19N1793000, 19N1895942, 19N1952247, 19N1884668, 19N1936498, 19N1936583, exp 3/31/2021; 19N1920630, 19N1958240, exp 4/30/2021; 19N1957675, M926001MA, M926002MA, M926003MA, M926004MA, M926005MA, M926006MA, M926007MA, M926008MA, M926009MA, M926201MA, M926202MA, exp 5/31/2021; M926201MB, M926202MB, M926203MB, M926204MB, M926205MB, M926206MB, M926207MB, M926208MB, M926209MB, exp 2/28/2021

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0996-2020