Altaire iSolutions Nano Tears Lubricant Gel Drops Recalled for Sterility Concerns
Altaire Pharmaceuticals is recalling iSolutions Nano Tears TF Clear Emollient 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or structural defects are rated Severe (4), and Class I/II drug recalls involving sterility issues are treated with high caution.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free Multi-Dose Mild Dry Eye Therapy, 0.25 FL OZ (7.5 mL). The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is identified by NDC 59390-141-52 and code 19123 4/21. The recall involves 24 units that were distributed nationwide in the United States.
Consumers with this product should stop using it and contact Altaire Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free Multi-Dose Mild Dry Eye Therapy, 0.25 FL OZ (7.5 mL), Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-52
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 24
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)
- 19123 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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