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Class II: temporary or reversible health riskTerminated

Glaxosmithkline Consumer Healthcare Holdings Childrens Robitussin Honey Cough and Chest Recall

Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppr…

Glaxosmithkline Consumer Healthcare Holdings · Warren, NJ

Risk level
Class II
Reported by FDA
Jul 8, 2020
Recall ID
D-1361-2020
Check your lot numberHow we source this data

Summary

Glaxosmithkline Consumer Healthcare Holdings recalled Childrens Robitussin Honey Cough and Chest starting Jun 16, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1361-2020 on Jul 8, 2020. Reason: Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. Status: Terminated.

Why it was recalled

Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.

Product description

Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottle (118 mL), Distributed by: Pfizer, Madison, NJ 07940 USA, UPC: 50300318760128, NDC: 0031-8760-12.

Lot numbers, UPCs & expiration codes

Lot #s: 02177, 02178, Exp. 01/31/2022

Where it was sold

Nationwide in the US

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-1361-2020
Classification
Class II
Status
Terminated
Recall initiated
Jun 16, 2020
FDA report date
Jul 8, 2020
Quantity
132,336 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Glaxosmithkline Consumer Healthcare Holdings

Original FDA data

Every field from FDA enforcement report D-1361-2020, exactly as published.

Show all FDA fields
City
Warren
State
NJ
Status
Terminated
Country
United States
Event ID
85848
Address
184 Liberty Corner Rd
Code information
Lot #s: 02177, 02178, Exp. 01/31/2022
Postal code
07059-6796
Report date
Jul 8, 2020
Product type
Drugs
Recall number
D-1361-2020
Classification
Class II
Recalling firm
Glaxosmithkline Consumer Healthcare Holdings
Product quantity
132,336 bottles
Termination date
Jun 3, 2022
Reason for recall
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottle (118 mL), Distributed by: Pfizer, Madison, NJ 07940 USA, UPC: 50300318760128, NDC: 0031-8760-12.
Distribution pattern
Nationwide in the US
Recall initiation date
Jun 16, 2020
Initial firm notification
Press Release
Center classification date
Jun 26, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1361-2020, published Jul 8, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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