The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0379-2020·Announced 2019-11-27

CVS Health Preservative Free Lubricant Eye Drops Recalled for Sterility Concerns

Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility. The recall covers 114,504 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 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 source text identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving sterility issues in medical products where hospitalization or significant injury risks are implied by the classification.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution. The recall is being conducted because of a lack of assurance of sterility in the product. The affected product consists of 30 sterile single-use containers, 0.02 fl. oz. (0.6 mL) each, Item #994883, distributed by CVS Pharmacy Inc.

The recall involves 114,504 units that were distributed nationwide in the U.S.A. The affected lot numbers are RGF 07/19, RHN 08/19, RIH 09/19, RJP 10/19, RKN 11/19, SDC 04/20, SFC 06/20, SFJ 06/20, SGI 07/20, SKF 11/20, and TAE 01/21.

Consumers should stop using the recalled eye drops and contact their healthcare provider or CVS Pharmacy for further instructions. 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 Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #994883, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428…
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
114,504

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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