Sandoz Recalls Gatifloxacin Ophthalmic Solution for Missing Package Insert
Sandoz Inc is recalling 76,644 bottles of Gatifloxacin Ophthalmic Solution 0.5% because the package insert is incorrect or missing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The issue is a packaging/labeling defect (missing insert) rather than a product contamination or safety hazard.
Plain-English summary
Sandoz Inc is recalling 76,644 bottles of Gatifloxacin Ophthalmic Solution 0.5% (NDC 61314-672-25). The product is a sterile, prescription-only ophthalmic solution manufactured by Alcon Laboratories, Inc. for Sandoz Inc. The recall is limited to Lot #289210F (Exp. 10/31/2019) and Lot #290632F (Exp. 10/31/2020).
The reason for the recall is a labeling issue: the package insert is incorrect or missing. The product was distributed nationwide in the U.S.
Consumers and healthcare providers should check their inventory for the affected lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or supplier for replacement or refund. Patients should contact their healthcare provider for guidance on alternative treatments if they have been using the affected product.
The recalled product
- Product
- GATIFLOXACIN (GATIFLOXACIN)
- Brand
- GATIFLOXACIN
- Manufacturer
- Sandoz Inc
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 76,644
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #s: 289210F
- Exp. 10/31/2019
- 290632F
- Exp. 10/31/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Sandoz Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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