D-1297-2019 Class II Terminated

Recalled by Unipharma, Llc. — Tamarac, FL

Recall Details

Product Type
Drugs
Report Date
May 22, 2019
Initiation Date
May 2, 2019
Termination Date
November 25, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
33360 cartons

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.

Distribution Pattern

Nationwide and Venezuela

Code Information

Lots: 80053; 80055 Exp. 10/31/20