D-1361-2020 Class II Terminated
FDA drug recall D-1361-2020 was initiated by Glaxosmithkline Consumer Healthcare Holdings on Jun 16, 2020 and is designated Class II. Reason for recall: Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. The recall status is terminated (terminated Jun 3, 2022). Affected quantity: 132,336 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 8, 2020
- Initiation Date
- Jun 16, 2020
- Termination Date
- Jun 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 132,336 bottles
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.
Reason for recall
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Distribution pattern
Nationwide in the US
Code information
Lot #s: 02177, 02178, Exp. 01/31/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1361-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026