CVS Children's Allergy Liquid Recalled for Potential B. cepacia Contamination
Unipharma is recalling CVS Health Children's Allergy Relief Liquid Medication due to a precautionary measure regarding 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, which aligns with the rubric for voluntary precautionary recalls.
Plain-English summary
Unipharma, Llc. is recalling CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution Antihistamine Mixed Berry Flavor. The product is distributed by CVS Pharmacy, Inc. and is identified by NDC 69842-261-01 and UPC 050428597156. The recall involves 27,840 cartons of the 20 single-use 0.17 fl. oz. (5 mL) format.
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 80058 and 80059, which have an expiration date of 11/30/20. The product was distributed nationwide and in Venezuela.
Consumers should check their medication for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, consumers should stop using it and contact CVS Pharmacy or Unipharma for further instructions.
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 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-261-01, UPC 050428597156
- Manufacturer
- Unipharma, Llc.
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 27,840
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: 80058
- 80059 Exp. 11/30/20
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.
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