The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0438-2020·Announced 2019-11-27

Altaire ActivEyes Lubricant Drops Recalled for Sterility Concerns

Altaire Pharmaceuticals is recalling ActivEyes Preservative Free Multi-Dose Lubricant Drops due to a lack of assurance of sterility. The recall affects 47 units distributed nationwide.

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 rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in sterile products) are categorized as Severe (Score 4), as they are not Class I (Critical) but involve significant risk.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling 47 units of ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF Sterile, 0.25 FL OZ (7.5 mL). The product is identified by NDC 59390-146-52 and code 18099 4/20. The recall was initiated because of a lack of assurance of sterility.

The affected product was distributed nationwide in the United States. 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 this product should stop using it and contact Altaire Pharmaceuticals, Inc. for further instructions or a refund. The recall is limited to the specific lot identified in the product information.

The recalled product

Product
ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF Sterile, 0.25 FL OZ (7.5 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-146-52
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
47

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)

  • 18099 4/20

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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