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 affects 45,864 units distributed nationwide.
What this means for you
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 the hazard involves a lack of assurance of sterility for a product applied to the eye, which poses a risk of harm without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling CVS Health Preservative Free Lubricant Eye Drops (Carboxymethycellulose 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 is distributed by CVS Pharmacy Inc. and consists of 60 sterile single-use containers, 0.02 fl. oz. (0.6 mL) each.
The recall involves 45,864 units of the product, which were distributed nationwide in the U.S.A. The specific lot numbers affected 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, and SGI 07/20. The product is identified by Item #495334 and UPC 0 50428 31010 6.
Consumers should check their eye drops for the listed lot numbers and stop using the product if it matches the recall description. The source text does not specify further consumer actions or contact information for the recalling firm.
The recalled product
- Product
- CVS Health Preservative Free Lubricant Eye Drops (Carboxymethycellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, Item #495334, 60 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 3
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 45,864
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.
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