Gatifloxacin Solution/ Drops
FDA Recall NDC 61314-672
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Gatifloxacin (NDC 61314-672). A significant event, classified as Class III, was initiated on Oct 17, 2019 by Sandoz Inc. The reported reason for this action was: "Labeling: Incorrect or missing package insert."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Incorrect or missing package insert.
Oct 17, 2019
Nov 06, 2019
76,644 bottles
Recall Profile & Regulatory Data
Event ID
84082
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sandoz Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Jan 19, 2022
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.
Batch or Lot Expiration Information
Lot# s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020
Affected Packages Involved in this Recall
61314-672-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
