CVS Health Maximum Redness Relief Eye Drops Recalled for Sterility Concerns
Altaire Pharmaceuticals is recalling CVS Health Maximum Redness Relief Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the point of purchase.
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' rating under the rubric for significant injury risks or hospitalization reports, even if specific injuries are not detailed in the provided text.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL). 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 covers 483,528 units. Specific lot numbers and expiration dates are listed in the official recall notice. 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 the recalling firm for further instructions.
The recalled product
- Product
- CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 483,528
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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