CVS Health Lubricant Eye Drops Recalled for Sterility Assurance Issues
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.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are typically scored as 4 (Severe), especially when involving sterility assurance issues for ophthalmic products which carry significant risk of infection.
Plain-English summary
Altaire Pharmaceuticals, Inc. is voluntarily recalling CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief (Item#: 563431, 15 mL) distributed by CVS Pharmacy, Inc. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product was distributed nationwide in the United States. The recall involves 222,096 units with specific lot codes and expiration dates listed in the agency's structured data. The agency 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.
Consumers who have purchased this product should stop using it immediately. They should return the product to the point of purchase for a refund or contact the recalling firm for further instructions. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Item#: 563431, 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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