The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0479-2020·Announced 2019-11-27

Altaire Recalls Nano Tears Lubricant Gel Drops Due to Sterility Concerns

Altaire Pharmaceuticals is recalling specific lots of Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops because the agency could not ensure the product was sterile.

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 FDA classified this recall as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the hazard involves a risk of harm such as sterility failure in a medical product, even if no injuries are currently reported.

Plain-English summary

Altaire Pharmaceuticals, Inc. is voluntarily recalling 2,870 units of Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL. The recall involves products with NDC 59390-144-51, specifically Lot #17367 (Exp 12/19) and Lot #18174 (Exp 7/20). The products were distributed nationwide in the United States.

The recall was initiated due to a lack of assurance of sterility. 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, or where the probability of serious adverse health consequences is remote.

Consumers who have purchased these specific lots should stop using the product and contact Altaire Pharmaceuticals for a refund or replacement. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-144-51
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Medical Device — Ophthalmic
Hazard
Affected units
2,870

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 (4)

  • Lot #: 17367
  • Exp 12/19
  • 18174
  • Exp 7/20

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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