The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0432-2020·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 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury or property damage reports, or high-risk conditions.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling 13,375 units of Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free (0.6 mL x 32 ct.). The product is identified by NDC 59390-141-56 and has a receipt date of July 19, 2019, a shelf date of April 20, 2020, and a use-by date of January 21, 2021.

The recall was initiated because of a lack of assurance of sterility. The product was distributed nationwide in the United States.

Consumers should stop using the product and contact the manufacturer for further instructions.

The recalled product

Product
Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct., Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-56
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
13,375

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)

  • RGI 7/19 SDB 4/20 TAA 1/21

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.

See all 134 products in this recall →

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