The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0403-2020·Announced 2019-11-27

CVS Health Lubricant Eye Drops Recalled for Sterility Assurance Concerns

Altaire Pharmaceuticals is recalling CVS Health Fast Acting Lubricant Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the pharmacy.

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. According to the rubric, an FDA Class II recall involving a significant hazard such as a lack of sterility assurance in a sterile product warrants a score of 4 (Severe).

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack (Item #994881). The recall involves 39,744 units distributed nationwide in the United States. The product is distributed by CVS Pharmacy, Inc.

The recall was initiated because of a lack of assurance of sterility. The affected lots have the following codes: 17296 (expiration 10/19), 18094 (expiration 04/20), and 18206 (expiration 08/20).

Consumers should stop using the product and return it to the pharmacy where it was purchased for a refund.

The recalled product

Product
CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item#: 994881, Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
39,744

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)

  • 17296 10/19 18094 04/20 18206 08/20

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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