The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0360-2020·Announced 2019-11-27

Altaire Lubricant Eye Drops Recalled for Lack of Sterility Assurance

Altaire Pharmaceuticals is recalling specific lots of Lubricant Eye Drops Moisturizing Twin Pack due to a lack of 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, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection associated with non-sterile eye drops.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Lubricant Eye Drops Moisturizing Twin Pack (Walgreens item #: 801477, NDC 0363-0185-49). The recall involves the 2 x 15 mL package size. The specific lot number is 19095, with an expiration date of 04/21.

The recall was initiated due to a lack of assurance of sterility. The product was distributed nationwide in the United States.

Consumers should stop using the affected product and return it to the point of purchase or contact the manufacturer for further instructions.

The recalled product

Product
Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477, Package Size: 2 x 15 mL, NDC 0363-0185-49
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — 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 (2)

  • Lot #: 19095
  • Exp 04/21

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.

See all →

Same hazard · lack of sterility

See all →

Similar recalls