The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0480-2020·Announced 2019-11-27

Altaire Nano Tears XP Lubricant Gel Recalled for Sterility Concerns

Altaire Pharmaceuticals is recalling Nano Tears XP 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in ophthalmic products) are categorized as Severe.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Nano Tears XP Clear Emollient Lubricant Gel Drops, twin pack (2 x 10 mL), NDC 59390-143-51. The specific lot affected is 17366, with an expiration date of 12/19. The product was distributed nationwide in the United States.

The recall was initiated due to a lack of assurance of sterility. This classification indicates that the product may not have been sterile as required, which could pose a risk to consumers using the eye drops.

Consumers should stop using the affected product and contact Altaire Pharmaceuticals for a refund or replacement. The FDA has classified this recall as Class II, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, Product Size: 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-143-51
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard

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 (2)

  • Lot #: 17366
  • Exp 12/19

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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