Childrens Robitussin Honey Cough And Chest Congestion Dm Solution
FDA Recall NDC 0031-8760
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Childrens Robitussin Honey Cough And Chest Congestion Dm (NDC 0031-8760). A significant event, classified as Class II, was initiated on Jun 16, 2020 by Haleon Us Holdings Llc. The reported reason for this action was: "Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Jun 16, 2020
Jul 08, 2020
132,336 bottles
Recall Profile & Regulatory Data
Event ID
85848
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Glaxosmithkline Consumer Healthcare Holdings
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Jun 03, 2022
Product Description
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
Affected Packages Involved in this Recall
0031-8760-12Product
5030031876Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
