The Recall Desk
SevereFDA (Drugs)·D-0433-2020·Announced 2019-11-27

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.

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 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
Hazard
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.

See all 134 products in this recall →

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Same hazard · sterility

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