FDAFDA · Food and drugs·Recall number D-0163-2020
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.
Published November 6, 2019 · Recall initiated: October 17, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Incorrect or missing package insert.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- GATIFLOXACIN
- Manufacturer
- Sandoz Inc
- Distributor
- Nationwide in the U.S.
- Lot
- Lot #s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.