The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0363-2020·Announced 2019-11-27

Altaire Recalls Walgreen's Lubricant Eye Ointment Due to Sterility Concerns

Altaire Pharmaceuticals is recalling Walgreen's Lubricant Eye Ointment because the product lacks assurance of sterility. The recall covers 45,672 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant risks such as sterility failures in ophthalmic products.

Plain-English summary

Altaire Pharmaceuticals, Inc. is voluntarily recalling 45,672 units of Walgreen's Lubricant Eye Ointment, Mineral Oil 42.5%/White Petrolatum 57.3%. The product is identified by NDC 0363-0191-50 and Item #801486. The specific lot affected is TDB with an expiration date of 4/22.

The recall was initiated because the product lacks assurance of sterility. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected product was distributed nationwide in the United States. Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Walgreen's Lubricant Eye Ointment, Mineral Oil 42.5%/White Petrolatum 57.3% /Eye Lubricant, Net Wt. 0.125 oz. (3.5g), Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Item #801486, NDC 0363-0191-50
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
45,672

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 #: TDB
  • Exp 4/22

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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