FDA recall D-1361-2020

Glaxosmithkline Consumer Healthcare Holdings · Class II · drug

Product

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.

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-1361-2020