CVS Health Lubricant Eye Drops Recalled for Sterility Concerns
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 pharmacy.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score according to the rubric. The hazard involves a lack of assurance of sterility in a medical product, which poses a significant risk of infection.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 1 fl. oz. (30 mL). 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 is available nationwide in the United States. The recall involves approximately 100,680 units. Specific lot numbers and expiration dates are listed in the official recall notice.
Consumers who have purchased this product should stop using it immediately and return it to the pharmacy where it was purchased for a refund or replacement. If you have any questions about this recall, please contact the recalling firm or your local CVS Pharmacy.
The recalled product
- Product
- CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Item #247887
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 100,680
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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