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Class II: temporary or reversible health riskTerminated

Glaxosmithkline Consumer Healthcare Holdings Childrens Dimetapp Cold & Cough Recall

Childrens Dimetapp Cold & Cough, For ages 6 yrs

Glaxosmithkline Consumer Healthcare Holdings · Warren, NJ

Risk level
Class II
Reported by FDA
Jul 8, 2020
Recall ID
D-1362-2020
Check your lot numberHow we source this data

Summary

Glaxosmithkline Consumer Healthcare Holdings recalled Childrens Dimetapp Cold & Cough starting Jun 16, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1362-2020 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 Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19.

Lot numbers, UPCs & expiration codes

Lot CL8292, Exp. 09/30/2021

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-1362-2020
Classification
Class II
Status
Terminated
Recall initiated
Jun 16, 2020
FDA report date
Jul 8, 2020
Quantity
78,132 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Glaxosmithkline Consumer Healthcare Holdings

Original FDA data

Every field from FDA enforcement report D-1362-2020, 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 CL8292, Exp. 09/30/2021
Postal code
07059-6796
Report date
Jul 8, 2020
Product type
Drugs
Recall number
D-1362-2020
Classification
Class II
Recalling firm
Glaxosmithkline Consumer Healthcare Holdings
Product quantity
78,132 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 Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19.
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-1362-2020, 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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