The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0376-2020·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. 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. According to the rubric, an FDA Class II recall with potential for adverse health consequences (such as infection from non-sterile eye drops) corresponds to a severity score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High risk due to the specific agency classification and potential for serious injury.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), Item #317914. The product is distributed by CVS Pharmacy, Inc. The recall is being conducted because of a lack of assurance of sterility.

The recall affects 531,936 units distributed nationwide in the U.S.A. The affected lot numbers are 17215 (07/19), 17239 (08/19), 18081 (03/21), 18207 (08/20), and 18274 (11/21).

Consumers should stop using the recalled eye drops and return them to the point of purchase for a refund or replacement. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), Item #317914, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
531,936

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 #: 17215 07/19 17239 08/19 18081 03/21 18207 08/20 18274 11/21

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 →

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