DrKids Nasal Saline Vials Recalled for Potential B. cepacia Contamination
Unipharma is recalling DrKids Himasal Natural Nasal Saline Solution vials 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 a voluntary precautionary measure due to potential contamination, with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Unipharma, LLC is voluntarily recalling DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Single-Use Vials. The recall is a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
The affected products are identified by the following lot numbers and expiration dates: Lot 90002 (Exp. 01/31/21) and Lot 90008 (Exp. 02/28/21). The recall covers 816 cartons distributed nationwide and in Venezuela.
Consumers should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Single-Use Vials, Drug Free, Manufactured by: Unipharma, LLC. Tamarac, FL 33321, a) 0.02 fl. oz. (0.5 mL), UPC 370302446081; b) 0.05 fl. oz. (1.5 mL), UPC 370302446098
- Manufacturer
- Unipharma, Llc.
- Category
- Drug — Nasal Saline
- Hazard
- Affected units
- 816
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: a) 90002 Exp. 01/31/21
- b) 90008 Exp. 02/28/21
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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- ModerateUnipharma Recalls DrKids Children's Allergy Relief Diphenhydramine Due to B. cepacia Risk
FDA (Drugs) · 2019-08-14
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