Class III
Terminated
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.
- Company
- Sandoz Inc
- Recall Initiated
- October 17, 2019
- Posted
- November 6, 2019
- Recall Number
- D-0163-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 76,644 bottles
- Firm Location
- Princeton, NJ, United States
Reason for Recall
Labeling: Incorrect or missing package insert.
Distribution
Nationwide in the U.S.
Lot / Code Info
Lot #s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020
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