DrKids Himasal Nasal Saline Recalled for Potential B. cepacia Contamination
Unipharma is recalling DrKids Himasal Natural Nasal Saline Solution vials due to a precautionary measure regarding potential contamination with B. cepacia bacteria.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), as it indicates a potential for temporary or medically reversible adverse health consequences.
Plain-English summary
Unipharma, LLC is recalling DrKids Himasal Natural Nasal Saline Solution, packaged in pre-measured single-use vials. The recall involves 456 cartons of the product, which is distributed nationwide in the United States. The affected lots include 80003 (Exp. 01/31/20), 70003 (Exp. 10/31/19), 70005 (Exp. 11/30/19), and 70006 (Exp. 11/30/19).
The recall is being conducted as a precautionary measure due to current good manufacturing practice (CGMP) deviations that pose a potential risk of product contamination with the bacteria B. cepacia. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have purchased these specific lots of DrKids Himasal Natural Nasal Saline Solution should stop using the product and contact Unipharma, LLC for further instructions or a refund.
The recalled product
- Product
- DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321
- Manufacturer
- Unipharma, Llc.
- Category
- Drug — Nasal Saline
- Hazard
- Affected units
- 456
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 (4)
- Lot: 80003 Exp. 01/31/20
- 70003 Exp. 10/31/19
- 70005 Exp. 11/30/19
- 70006 Exp. 11/30/19
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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