CVS Health Lubricant Eye Drops Recalled for Sterility Assurance Concerns
Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility. The recall covers 39,744 units distributed nationwide.
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/property-damage reports or hospitalization are rated Severe. While specific injury reports are not detailed in the provided text, the agency classification of Class II for a sterility issue in an ophthalmic product aligns with the Severe criteria for significant potential harm.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling CVS Health Preservative Free Lubricant Eye Drops Dry Eye Therapy, Twin Pack (Item #994881, 2 x 10 mL). The recall is being conducted due to a lack of assurance of sterility. The product is distributed by CVS Pharmacy Inc.
The recall affects 39,744 units distributed nationwide in the U.S.A. The specific lots involved are 17296 (10/19), 18094 (04/20), and 18206 (08/20).
Consumers should check their eye drops for the listed lot numbers and stop using the product if it matches. They should contact CVS Pharmacy Inc. or Altaire Pharmaceuticals for further instructions on disposal or return.
The recalled product
- Product
- CVS Health Preservative Free 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)
- Lot #: 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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