CVS Health Lubricant Eye Drops Recalled for Sterility Assurance Issues
Altaire Pharmaceuticals is recalling CVS Health Lubricant Eye Drops Advanced Relief due to a lack of assurance of sterility. Consumers should stop using the product and contact CVS Pharmacy for a refund.
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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall with potential for adverse health consequences (lack of sterility in eye drops) corresponds to a severity score of 4 (Severe), as it is not Class I but involves a significant risk of infection or injury.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling CVS Health Lubricant Eye Drops Advanced Relief (Item#: 563419, 10 mL) because of a lack of assurance of sterility. The product was distributed by CVS Pharmacy, Inc. in Woonsocket, RI, and was available nationwide in the United States.
The recall involves 48,168 units. The specific lot codes affected are 17285 (09/19), 18067 (03/20), 18205 (08/20), and 18067 (3/20). The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers who have purchased this product should stop using it immediately. They should contact CVS Pharmacy, Inc. for a refund or further instructions. The recall is being conducted to ensure the safety and quality of the product for consumers.
The recalled product
- Product
- CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 48,168
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 17285 09/19 18067 03/20 18205 08/20 18067 3/20
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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