Recalls / Class II
Class IID-1361-2020
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.
- Brand name
- Childrens Robitussin Honey Cough And Chest Congestion Dm
- Generic name
- Dextromethorphan Hbr, Guaifenesin
- Active ingredients
- Dextromethorphan Hydrobromide, Guaifenesin
- Route
- Oral
- NDC
- 0031-8760
- FDA application
- M012
- Affected lot / code info
- Lot #s: 02177, 02178, Exp. 01/31/2022
Why it was recalled
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Recalling firm
- Firm
- Glaxosmithkline Consumer Healthcare Holdings
- Manufacturer
- Haleon US Holdings LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 184 Liberty Corner Rd, N/A, Warren, New Jersey 07059-6796
Distribution
- Quantity
- 132,336 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2020-06-16
- FDA classified
- 2020-06-26
- Posted by FDA
- 2020-07-08
- Terminated
- 2022-06-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1361-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.