D-1306-2019 Class II Terminated
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
- 21456 cartons
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.
Distribution Pattern
Nationwide and Venezuela
Code Information
Lots: 80054; 80056 Exp. 10/31/20