CVS Children's Cough Syrup Recalled for Potential B. cepacia Contamination
Unipharma, LLC is recalling CVS Health Children's Cough Syrup due to potential contamination with B. cepacia bacteria.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, with no reported illnesses or injuries in the source text.
Plain-English summary
Unipharma, LLC is recalling CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor, 20 Single-Use 0.08 fl. oz. (2.5 mL). The product is distributed by CVS Pharmacy, Inc. The recall involves 38,640 cartons of the medication.
The recall is being conducted as a precautionary measure due to Current Good Manufacturing Practice (CGMP) deviations that created a potential risk of product contamination with the bacteria B. cepacia. The affected lots are 80043 (Expiration 07/05/20) and 80047 (Expiration 07/31/20). The product was distributed nationwide and in Venezuela.
Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If they have the affected product, they should stop using it and contact CVS Pharmacy or Unipharma for further instructions or a refund.
The recalled product
- Product
- CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08 fl. oz. (2.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 050428597958
- Manufacturer
- Unipharma, Llc.
- Category
- Drug — Cough Syrup
- Hazard
- Affected units
- 38,640
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: 80043 Exp. 07/05/20
- 80047 Exp. 07/31/20
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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Similar recalls
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- SevereKingston Pharma Recalls Infant Cough Syrup Due to Microbial Contamination
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