PlainRecalls
FDA Drug Moderate Class II Terminated

CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01, UPC 050428598368

Reported: May 22, 2019 Initiated: May 2, 2019 #D-1306-2019

Product Description

CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01, UPC 050428598368

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
21456 cartons
Distribution
Nationwide and Venezuela
Location
Tamarac, FL

Frequently Asked Questions

What product was recalled?
CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01, UPC 050428598368. Recalled by Unipharma, Llc.. Units affected: 21456 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-1306-2019.