The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0387-2020·Announced 2019-11-27

CVS Health Lubricant Eye Drops Recalled for Sterility Concerns

Altaire Pharmaceuticals is recalling CVS Health Fast Acting Lubricant Eye Drops due to a lack of assurance of sterility. The recall affects 238,968 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Propylene Glycol 0.3%) Dry Eye Therapy, Sterile, 0.5 fl. oz. (15 mL), Item #895160. The recall is being conducted due to a lack of assurance of sterility. The product is distributed by CVS Pharmacy Inc.

The recall involves 238,968 units of the eye drops. The affected lots are 17223 (07/19), 17297 (10/19), 18017 (01/20), 18018 (01/20), 18065 (03/21), 18213 (08/20), and 18247 (10/21). The product was distributed nationwide in the United States.

Consumers should stop using the recalled eye drops and return them to the point of purchase for a refund or contact the distributor for further instructions. The FDA classifies this recall as Class II, indicating a situation in which there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Propylene Glycol 0.3%) Dry Eye Therapy, Sterile, 0.5 fl. oz. (15 mL), Item #895160, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
238,968

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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