Altaire Recalls Nano Tears Lubricant Gel Drops Due to Sterility Concerns
Altaire Pharmaceuticals is recalling Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops because the product lacks 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, and the hazard involves a lack of assurance of sterility in a medical product, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack (2 x 10 mL, NDC 59390-144-51). The recall was initiated because the product lacks assurance of sterility.
The affected product was distributed nationwide in the United States. The source text identifies specific lot codes 17367 12/19 and 18174 7/20.
Consumers should stop using the product and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10 mL, NDC 59390-144-51
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Medical Device — 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 (1)
- 17367 12/19 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.
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