Altaire Nano Tears Lubricant Gel Drops Recalled for Sterility Concerns
Altaire Pharmaceuticals is recalling Nano Tears TF Clear Emollient Lubricant Gel Drops due to a lack of assurance of sterility. The recall covers 1,666 units distributed nationwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly when involving sterility assurance issues for ophthalmic products which carry significant risk of infection.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack (2 x 15 mL), NDC 59390-142-49. The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product was manufactured by Altaire Pharmaceuticals, Inc. in Aquebogue, NY. A total of 1,666 units were distributed nationwide in the United States. The specific lot code for the recalled product is 18033 2/20.
Consumers who have this product should stop using it and contact Altaire Pharmaceuticals, Inc. for further instructions or a refund. 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.
The recalled product
- Product
- Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 15 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-49
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 1,666
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)
- 18033 2/20
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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