Drug product
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.
D-0163-2020
Product summary
- Firm
- Sandoz Inc
- Event
- Event 84082
- Status
- Terminated
- Classification
- Class III
- Quantity
- 76,644 bottles
- Official record key
drug-enforcement:D-0163-2020
Official wording
Reason: Labeling: Incorrect or missing package insert.
Code information: Lot #s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or missing