Altaire NanoTears Lubricant Gel Drops Recalled for Sterility Concerns
Altaire Pharmaceuticals is recalling 137 units of iSolutions NanoTears HA Preservative Free Multi-Dose Lubricant Gel Drops due to a lack of assurance of sterility.
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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for adverse health consequences (such as sterility issues in sterile products) map to a score of 4 (Severe) when injury reports or specific high-risk pathogens are not explicitly detailed as 'Critical' or 'High' in the text, but the defect is structural/sterility-related.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling 137 units of iSolutions NanoTears HA Preservative Free Multi-Dose Lubricant Gel Drops Sterile, 0.33 FL OZ (10 mL). The product is identified by NDC 59390-208-10 and code 19122 4/21. The recall was initiated because of a lack of assurance of sterility.
The affected units were distributed nationwide in the United States. The source text does not specify the exact number of units distributed in each state or the specific retail locations where the product was sold.
Consumers who have this product should stop using it and contact Altaire Pharmaceuticals, Inc. for further instructions or a refund. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- iSolutions NanoTears HA Preservative Free Multi - Dose Lubricant Gel Drops Sterile, 0.33 FL OZ (10 mL), Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-208-10
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 137
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)
- 19122 4/21
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 134 recalled by Altaire Pharmaceuticals, Inc. 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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