CVS Health Children's Mucus Relief Recalled for B. cepacia Contamination Risk
Unipharma, LLC is recalling CVS Health Children's Mucus Relief Chest Congestion Plus Cough 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 classified as FDA Class II and is explicitly described as a precautionary measure due to potential contamination risk, fitting the rubric for voluntary precautionary recalls or low-risk contamination without reported illness.
Plain-English summary
Unipharma, LLC is recalling CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor. The product is distributed by CVS Pharmacy, Inc. and is available in 20 single-use vials per carton (0.17 fl. oz. / 5 mL). The recall involves 33,360 cartons with lot numbers 80053 and 80055, which have an expiration date of 10/31/20.
The recall is being conducted as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. This action is classified as an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected product was distributed nationwide and in Venezuela. Consumers should check their home medicine cabinets for this specific product and lot numbers. If found, they should stop using the product and contact CVS Pharmacy, Inc. or Unipharma, LLC for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- 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 69842-26
- Manufacturer
- Unipharma, Llc.
- Category
- Drug — Cough and Cold Medication
- Hazard
- Affected units
- 33,360
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: 80053
- 80055 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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