FDA Drug Recalls

Recalls / Class II

Class IID-1362-2020

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.

Affected lot / code info
Lot CL8292, Exp. 09/30/2021

Why it was recalled

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

Recalling firm

Firm
Glaxosmithkline Consumer Healthcare Holdings
Notification channel
Press Release
Type
Voluntary: Firm initiated
Address
184 Liberty Corner Rd, N/A, Warren, New Jersey 07059-6796

Distribution

Quantity
78,132 bottles
Distribution pattern
Nationwide in the US

Timeline

Recall initiated
2020-06-16
FDA classified
2020-06-26
Posted by FDA
2020-07-08
Terminated
2022-06-03
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1362-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls