CVS Health Lubricant Eye Drops Recalled for Sterility Assurance Concerns
Altaire Pharmaceuticals is recalling CVS Health Fast Acting Lubricant Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the pharmacy.
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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as a lack of sterility assurance in a sterile product warrants a score of 4 (Severe).
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack (Item #994881). The recall involves 39,744 units distributed nationwide in the United States. The product is distributed by CVS Pharmacy, Inc.
The recall was initiated because of a lack of assurance of sterility. The affected lots have the following codes: 17296 (expiration 10/19), 18094 (expiration 04/20), and 18206 (expiration 08/20).
Consumers should stop using the product and return it to the pharmacy where it was purchased for a refund.
The recalled product
- Product
- CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item#: 994881, Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 39,744
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)
- 17296 10/19 18094 04/20 18206 08/20
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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