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.
D-1361-2020
Product summary
- Event
- Event 85848
- Status
- Terminated
- Classification
- Class II
- Quantity
- 132,336 bottles
- Official record key
drug-enforcement:D-1361-2020
Official wording
Reason: Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Code information: Lot #s: 02177, 02178, Exp. 01/31/2022
Distribution pattern: Nationwide in the US
Derived failure modes
-
Unknown
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.