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 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a critical sterility failure in a sterile product, are classified as Severe (Score 4).
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz. (15 mL). The product is distributed by CVS Pharmacy Inc. The recall is being conducted because of a lack of assurance of sterility.
Approximately 22,209 units of the product were distributed nationwide in the United States. The affected lots include codes 18043, 18115, 18300, and 18116, with expiration dates ranging from February 2020 to December 2020.
Consumers should stop using the recalled eye drops immediately. The product should be returned to the point of purchase for a refund or replaced with a non-recalled item.
The recalled product
- Product
- CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, 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
- 222,096
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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