The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0429-2020·Announced 2019-11-27

Altaire Pharmaceuticals Recalls iSolutions Nano Tears MXP Forte Due to Sterility Concerns

Altaire Pharmaceuticals is recalling iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops because the company cannot ensure the product is 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility assurance issues for ophthalmic products.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 mL, NDC 59390-144-10. The recall was initiated because the manufacturer lacks assurance of the product's sterility.

The affected product was distributed nationwide in the United States. The recall covers 13,407 units with lot codes 17367 (expiration 12/19), 18102 (expiration 4/20), and 18174 (expiration 7/20).

Consumers should check their inventory for these specific lot codes and stop using the product if it matches the recalled items. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-144-10
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
13,407

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)

  • 17367 12/19 18102 4/20 18174 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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