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Recall Observatory FDA recall evidence

Drug product

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.

D-1362-2020

June 16, 2020

Class II

Product summary

Firm
Glaxosmithkline Consumer Healthcare Holdings
Event
Event 85848
Status
Terminated
Classification
Class II
Quantity
78,132 bottles
Official record key
drug-enforcement:D-1362-2020

Official wording

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

Code information: Lot CL8292, Exp. 09/30/2021

Distribution pattern: Nationwide in the US

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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