D-0163-2020 Class III Terminated
FDA drug recall D-0163-2020 was initiated by Sandoz Inc on October 17, 2019 and is designated Class III. Reason for recall: Labeling: Incorrect or missing package insert. The recall status is terminated (terminated January 19, 2022). Affected quantity: 76,644 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 6, 2019
- Initiation Date
- October 17, 2019
- Termination Date
- January 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76,644 bottles
Product Description
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.
Reason for Recall
Labeling: Incorrect or missing package insert.
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020