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
- non-sterility
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.
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