FDA-Drug2019-05-22Class II

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

Unipharma, Llc.
Hazard

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

Sold states
Nationwide and Venezuela
Affected count
21456 cartons
Manufactured in
10200 NW 67th St, Tamarac, FL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1306-2019

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