Why it was recalled
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.
Product 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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0996-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 23, 2019
- FDA report date
- Feb 19, 2020
- Quantity
- 431,614 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GSK Consumer Health, Inc
Original FDA data
Every field from FDA enforcement report D-0996-2020, exactly as published.
Show all FDA fields
- City
- Lincoln
- State
- NE
- Status
- Terminated
- Country
- United States
- Event ID
- 84931
- Address
- 10401 Hwy 6
- Code information
- 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
- Postal code
- 68517-9626
- Report date
- Feb 19, 2020
- Product type
- Drugs
- Recall number
- D-0996-2020
- Classification
- Class II
- Recalling firm
- GSK Consumer Health, Inc
- Product quantity
- 431,614 cartons
- Termination date
- Mar 9, 2023
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Dec 23, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 7, 2020