Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Sandoz Inc
- Reason for Recall:
- Labeling: Incorrect or missing package insert.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25.
Product Codes/Lot Numbers:
Lot #s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0163-2020
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