Multi-event June 2020 FDA Recall Childrens Robitussin Honey Cough And Chest Congestion Dm by Glaxosmithkline Consumer Healthcare Holdings
This Multi-event Class II drug recall was voluntarily initiated by Glaxosmithkline Consumer Healthcare Holdings on June 16, 2020 for the product Childrens Robitussin Honey Cough And Chest Congestion Dm. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1362-2020
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
06-16-2020
07-08-2020
78,132 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glaxosmithkline Consumer Healthcare Holdings
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
06-03-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# Lot CL8292, Exp. 09/30/2021
Recall Number: D-1361-2020
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
06-16-2020
07-08-2020
132,336 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glaxosmithkline Consumer Healthcare Holdings
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
06-03-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# s: 02177, 02178, Exp. 01/31/2022
