CVS Children's Allergy Relief Liquid Medication Recalled for Potential B. cepacia Contamination
Unipharma is recalling CVS Health Children's Allergy Relief Liquid Medication due to potential contamination with B. cepacia bacteria. The recall is a precautionary measure.
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 explicitly described as a precautionary measure due to potential contamination, with no reported illnesses or injuries, which aligns with the criteria for a Moderate severity score.
Plain-English summary
Unipharma, LLC is recalling CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Mixed Berry Flavor. The product is distributed by CVS Pharmacy, Inc. and consists of 20 single-use vials per carton.
The recall is being conducted as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. This action follows Current Good Manufacturing Practice (CGMP) deviations. The source text does not report any illnesses or injuries associated with this product.
The affected product is identified by Lot 80060 with an expiration date of 11/30/20. A total of 48 cartons were distributed nationwide in the US. Consumers should stop using the product and follow instructions from the recalling firm or their healthcare provider.
The recalled product
- Product
- CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL) Total Distributed by: CVS Pharmacy, Inc. One CVS Drive…
- Manufacturer
- Unipharma, Llc.
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 48
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 (1)
- Lot: 80060 Exp. 11/30/20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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.
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