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.
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 under the rubric for drug recalls involving potential serious health consequences.
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), Item #994880. The recall is being conducted because of a lack of assurance of sterility.
The affected product was distributed nationwide in the U.S.A. by CVS Pharmacy Inc. A total of 483,528 units are involved in this recall. The specific lot codes affected are 17251 8/19, 17269 9/19, 17360 12/19, 18012 1/20, 18106 4/20, and 18275 11/20.
Consumers should check their eye drops for these specific lot codes. If the product matches the recalled description, consumers should stop using it and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz., (15 mL), Item #994880, 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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