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.
Reported: November 6, 2019 Initiated: October 17, 2019 #D-0163-2020
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.
Details
- Recalling Firm
- Sandoz Inc
- Units Affected
- 76,644 bottles
- Distribution
- Nationwide in the U.S.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sandoz Inc. Units affected: 76,644 bottles.
Why was this product recalled? ▼
Labeling: Incorrect or missing package insert.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 6, 2019. Severity: Low. Recall number: D-0163-2020.
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