CVS Children's Nasal Saline Drops Recalled for B. cepacia Contamination Risk
Unipharma, LLC is recalling CVS Health Children's Nasal Saline Drops due to a precautionary measure regarding 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 risk, which aligns with the rubric for voluntary precautionary recalls.
Plain-English summary
Unipharma, LLC is recalling 48 cartons of CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer. The product is distributed by CVS Pharmacy, Inc. and was sold nationwide in the US. The specific lot number is 90008 with an expiration date of 02/28/21.
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 agency has classified this recall as Class II.
Consumers who have this product should check their lot numbers and expiration dates. If they possess the affected lot, they should stop using the product and contact CVS Pharmacy or Unipharma for further instructions.
The recalled product
- Product
- CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer, 30 single-use vials per Carton,0.05 fl. oz. (1.5 mL) each 1.5 fl. oz. (45 mL) total, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207
- Manufacturer
- Unipharma, Llc.
- Category
- Drug — Nasal Saline
- 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: 90008 Exp. 02/28/21
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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