CVS Health Lubricant Gel Drops Recalled for Sterility Assurance Issues
Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Gel Drops due to a lack of assurance of sterility.
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 classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe. While no injuries are explicitly reported, the lack of sterility assurance in a drug product is a significant safety hazard that aligns with the Severe criteria for Class II recalls where the risk is not merely theoretical or cosmetic.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief (Item#: 634634). The product is distributed by CVS Pharmacy, Inc. and consists of 0.6 mL x 30 units.
The recall was initiated because of a lack of assurance of sterility. The source text does not specify the exact cause of the sterility concern or report any specific illnesses or injuries associated with the product.
Approximately 114,504 units were distributed nationwide in the U.S.A. Consumers should stop using the product and contact CVS Pharmacy or Altaire Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Item#: 634634, Product Size: 0.6 mL x 30, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 114,504
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)
- SEI 5/20 TAK 01/21
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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