FDAFDA · Food and drugs·Recall number D-1306-2019
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
Published May 22, 2019 · Recall initiated: May 2, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Unipharma, Llc.
- Distributor
- Nationwide and Venezuela
- Lot
- Lots: 80054; 80056 Exp. 10/31/20
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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