The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0411-2020·Announced 2019-11-27

CVS Health Redness Relief Eye Drops Recalled for Sterility Concerns

Altaire Pharmaceuticals is recalling CVS Health Redness Relief Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the point of purchase.

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 and involves a lack of assurance of sterility in a product intended for direct application to the eye, which poses a significant risk of serious injury or infection.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Item #317912. The recall is being conducted because of a lack of assurance of sterility in the product. The affected units were distributed nationwide in the United States by CVS Pharmacy Inc.

The recall involves 464,424 units. Specific lot codes associated with the recall include 18229 9/21, 18031 1/21, 17131 5/20, 17059 3/20, 17008 1/20, and 19056 03/22. The U.S. Food and Drug Administration has classified this as a Class II recall.

Consumers who have purchased these eye drops should stop using them immediately. They should return the product to the point of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Item #317912, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
464,424

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)

  • 18229 9/21 18031 1/21 17131 5/20 17059 3/20 17008 1/20 19056 03/22

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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