Drug product
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.
D-1490-2019
Product summary
- Event
- Event 83333
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,238 bottles
- Official record key
drug-enforcement:D-1490-2019
Official wording
Reason: Labeling: Missing label; Product complaints reported missing bottle label.
Code information: Lot #: H805157, Exp. 05/2020
Distribution pattern: Nationwide in the U.S. and PR.
Derived failure modes
-
Labeling or packaging
Labeling: Missing