CVS Health Lubricant Eye Drops Recalled for Lack of Sterility Assurance
Altaire Pharmaceuticals is recalling CVS Health Lubricant Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the point of purchase.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant health consequences (such as loss of sterility in ophthalmic products) fall under the 'Severe' category, particularly when structural or sterility defects are involved.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl. oz. (15 mL), Item #317916. The recall was initiated because of a lack of assurance of sterility in the product. The affected units were distributed nationwide in the United States by CVS Pharmacy, Inc.
The recall involves 365,832 units across multiple lots, including lot numbers 17196, 17192, 17355, 18024, 18036, 18237, 18293, 18105, 18179, and 19040. The expiration dates for these lots range from August 2019 to February 2021. The product is manufactured by Altaire Pharmaceuticals, Inc. and distributed by CVS Pharmacy, Inc. in Woonsocket, Rhode Island.
Consumers who have purchased these eye drops should stop using them immediately. They should return the product to the point of purchase for a refund or contact CVS Pharmacy for further instructions. This recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl. oz. (15 mL), Item #317916, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 365,832
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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