The Recall Desk
SevereFDA (Drugs)·D-0428-2020·Announced 2019-11-27

Altaire iSolutions Nano Tears Lubricant Drops Recalled for Sterility Concerns

Altaire Pharmaceuticals is recalling iSolutions Nano Tears MO Clear Emollient Lubricant Drops due to a lack of assurance of sterility.

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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility assurance issues for sterile products.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling 2,392 units of iSolutions Nano Tears MO Clear Emollient Lubricant Drops Intensive Sterile, 10 mL. The product is identified by NDC 59390-145-10 and code 18052 2/20. The recall was initiated because of a lack of assurance of sterility.

The affected units were distributed nationwide in the United States. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have this product should stop using it and contact Altaire Pharmaceuticals, Inc. for further instructions or a refund.

The recalled product

Product
iSolutions Nano Tears MO Clear Emollient Lubricant Drops Intensive Sterile, 10 mL, Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390- 145-10
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
2,392

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)

  • 18052 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 →

Related recalls

Same manufacturer · Altaire Pharmaceuticals, Inc.

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Same hazard · sterility

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