Why it was recalled
Labeling: Incorrect or missing package insert.
Product 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.
Lot numbers, UPCs & expiration codes
Lot #s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0163-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 17, 2019
- FDA report date
- Nov 6, 2019
- Quantity
- 76,644 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0163-2020, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84082
- Address
- 100 College Rd W
- Code information
- Lot #s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020
- Postal code
- 08540-6604
- Report date
- Nov 6, 2019
- Product type
- Drugs
- Recall number
- D-0163-2020
- Classification
- Class III
- Recalling firm
- Sandoz Inc
- Product quantity
- 76,644 bottles
- Termination date
- Jan 19, 2022
- Reason for recall
- Labeling: Incorrect or missing package insert.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Oct 17, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 28, 2019