The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0407-2020·Announced 2019-11-27

CVS Health Lubricant Eye Drops Recalled for Sterility Assurance Issues

Altaire Pharmaceuticals is recalling CVS Health Lubricant Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product.

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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance for a sterile eye drop product, which poses a significant risk of infection and potential injury.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Lubricant Eye Drops (Propylene Glycol 0.6%) Lasting Dry Eye Relief, Sterile, 0.33 fl. oz. (10 mL), Item #968210. The recall is being conducted because of a lack of assurance of sterility. The product is distributed by CVS Pharmacy Inc.

The recall affects 66,159 units distributed nationwide in the U.S.A. The specific lot codes involved are 17291 9/19, 17385 12/19, 18118 5/20, and 18266 10/20.

Consumers should stop using the recalled eye drops and return them to the place of purchase or contact the recalling firm for instructions.

The recalled product

Product
CVS Health Lubricant Eye Drops (Propylene Glycol 0.6%) Lasting Dry Eye Relief, Sterile, 0.33 fl. oz. (10 mL), Item #968210, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
Affected units
66,159

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)

  • 17291 9/19 17385 12/19 18118 5/20 18266 10/20

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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