D-1490-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 24, 2019
- Initiation Date
- July 11, 2019
- Termination Date
- September 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,238 bottles
Product Description
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.
Reason for Recall
Labeling: Missing label; Product complaints reported missing bottle label.
Distribution Pattern
Nationwide in the U.S. and PR.
Code Information
Lot #: H805157, Exp. 05/2020