The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0373-2020·Announced 2019-11-27

CVS Health Natural Tears Lubricant Eye Drops Recalled for Sterility Concerns

Altaire Pharmaceuticals is recalling CVS Health Natural Tears Lubricant Eye Drops due to a lack of assurance of sterility. The recall affects 152,369 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 (sterile eye drops) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical risk without confirmed illness.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic Solution, Sterile, 0.02 Fl. oz. (0.6 mL) each, 32 Single Use Vials, Item #538397. The product is distributed by CVS Pharmacy, Inc. The recall is being conducted because of a lack of assurance of sterility.

The recall involves 152,369 units of the product. The affected lot numbers are SEI 5/21, SGC 7/21, QGB 07/19, QID 09/19, RJC 10/20, RCJ 03/20, RCB 03/20, and TCJ 03/22. The product was distributed nationwide in the United States.

Consumers should stop using the recalled product and check their lot numbers against the list provided. The source text does not specify specific consumer actions beyond the recall itself, nor does it report any illnesses or injuries associated with the product.

The recalled product

Product
CVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic Solution, Sterile, 0.02 Fl. oz., (0.6 mL) each, 32 Single Use Vials, Item #538397, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic Solution
Hazard
Affected units
152,369

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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