Recalls / Class III
Class IIID-0163-2020
Product
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.
- Brand name
- Gatifloxacin
- Generic name
- Gatifloxacin
- Active ingredient
- Gatifloxacin
- Route
- Ophthalmic
- NDC
- 61314-672
- FDA application
- ANDA204227
- Affected lot / code info
- Lot #s: 289210F, Exp. 10/31/2019; 290632F, Exp. 10/31/2020
Why it was recalled
Labeling: Incorrect or missing package insert.
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 76,644 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-10-17
- FDA classified
- 2019-10-28
- Posted by FDA
- 2019-11-06
- Terminated
- 2022-01-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0163-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.