Drug: CVS Health Lubricant Gel Drops recalled nationwide for non-sterility
CVS Health Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) are being recalled nationwide due to non-sterility concerns. All lots of the product in single and twin pack bottles are affected.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This recall is classified by the FDA as Class I. Per the severity rubric, FDA Class I recalls are classified as Critical (score 5).
Plain-English summary
CVS Health brand Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) are being recalled. The recalled product includes 0.5 FL OZ (15 mL) bottles in single pack (NDC 76168-704-15) and twin pack (NDC 76168-704-30) configurations. A total of 150,720 bottles were affected. The product is distributed nationwide within the United States.
The recall was initiated due to non-sterility of the product. The product is manufactured by Kilitch Healthcare India Limited and distributed by CVS Pharmacy Inc.
This is a voluntary recall initiated by the firm. The manufacturer initiated the recall on November 13, 2023. The FDA classified it as Class I on February 5, 2024.
Consumers should discontinue use of this product and return it to the place of purchase for a refund. For additional information, consumers can contact CVS Pharmacy or the FDA.
The recalled product
- Product
- CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Ophthalmic / Eye drops
- Hazard
- Affected units
- 150,720
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)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Kilitch Healthcare India Limited 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.
See all 22 products in this recall →Related recalls
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