CVS Health Lubricant Gel Drops Recalled for Sterility Assurance Issues
Altaire Pharmaceuticals is recalling CVS Health Extra Strength Lubricant Gel Drops due to a lack of assurance of sterility. The recall affects 159,864 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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this context, a critical sterility failure for a sterile product, align with a Severe rating (Score 4), as it poses a significant risk of infection or serious harm.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling CVS Health Extra Strength Lubricant Gel Drops, Sterile 0.5 FL OZ (15 mL). The recall is being conducted because of a lack of assurance of sterility in the product. The product is distributed by CVS Pharmacy, Inc.
The recall involves 159,864 units of the lubricant gel drops. The affected products were distributed nationwide in the United States. Specific lot codes associated with the recall include 19087 3/21, 17289 9/19, 19087 03/21, and 18122 5/20.
Consumers should check their inventory for these specific lot codes. If you have this product, you should stop using it and contact CVS Pharmacy or Altaire Pharmaceuticals for further instructions on how to return the product or obtain a refund.
The recalled product
- Product
- CVS Health Extra Strength Lubricant Gel Drops, Sterile 0.5 FL OZ (15 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic / Lubricant
- Affected units
- 159,864
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)
- 19087 3/21 17289 9/19 19087 03/21 18122 5/20
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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