PlainRecalls
FDA Drug Moderate Class II Terminated

CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor 20 Singe-Use Vials Per Carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-260-01, UPC 050428597675

Reported: May 22, 2019 Initiated: May 2, 2019 #D-1297-2019

Product Description

CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor 20 Singe-Use Vials Per Carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-260-01, UPC 050428597675

Reason for Recall

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Details

Recalling Firm
Unipharma, Llc.
Units Affected
33360 cartons
Distribution
Nationwide and Venezuela
Location
Tamarac, FL

Frequently Asked Questions

What product was recalled?
CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor 20 Singe-Use Vials Per Carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-260-01, UPC 050428597675. Recalled by Unipharma, Llc.. Units affected: 33360 cartons.
Why was this product recalled?
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 22, 2019. Severity: Moderate. Recall number: D-1297-2019.