The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0377-2020·Announced 2019-11-27

CVS Health Dry Eye Relief Lubricant Eye Drops Recalled for Sterility Concerns

Altaire Pharmaceuticals is recalling CVS Health Dry Eye Relief Lubricant Eye Drops due to a lack of assurance of sterility. The recall affects 101,712 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. According to the rubric, an FDA Class II recall involving a significant hazard like lack of sterility in an ophthalmic product is rated as Severe (4).

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 1 Fl. Oz. (30 mL), Item #457802. The recall is being conducted because of a lack of assurance of sterility. The product is distributed by CVS Pharmacy Inc. in Woonsocket, RI.

The recall involves 101,712 units of the eye drops. The affected lots are 17277 09/19, 18006 01/20, 18098 04/21, 18006 1/20, and 19057 02/22. The product was distributed nationwide in the U.S.A.

Consumers should stop using the recalled product and return it to the place of purchase for a refund or follow instructions provided by the recalling firm.

The recalled product

Product
CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 1 Fl. Oz. (30 mL), Item #457802, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
101,712

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)

  • Lot #: 17277 09/19 18006 01/20 18098 04/21 18006 1/20 19057 02/22

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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