CVS Children's Cough Syrup Recalled for Potential B. cepacia Contamination
Unipharma is recalling CVS Health Children's Cough & Chest Congestion DM due to potential contamination with B. cepacia bacteria.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is explicitly described as a 'precautionary measure' due to 'potential risk' of contamination, with no reported illnesses or injuries, which aligns with the Moderate severity criteria for voluntary precautionary recalls.
Plain-English summary
Unipharma, LLC is recalling 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. The recall is being conducted as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
The affected product is distributed by CVS Pharmacy, Inc. and was distributed nationwide and in Venezuela. The recall involves 21,456 cartons with lot numbers 80054 and 80056, which have an expiration date of 10/31/20.
Consumers should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- 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,
- Manufacturer
- Unipharma, Llc.
- Category
- Drug — Cough & Cold Medicine
- Hazard
- Affected units
- 21,456
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: 80054
- 80056 Exp. 10/31/20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Unipharma, Llc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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FDA (Drugs) · 2019-08-14
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