FDA recall D-1362-2020

Glaxosmithkline Consumer Healthcare Holdings · Class II · 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.

Reason for recall

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

Distribution

Nationwide in the US

Key facts

Status
Terminated
Initiation date
2020-06-16
Report date
2020-07-08
Termination date
2022-06-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1362-2020