Lupin Recalls Gatifloxacin Ophthalmic Solution Due to Missing Labels
Lupin Pharmaceuticals is recalling 17,238 bottles of Gatifloxacin Ophthalmic Solution 0.5% because some bottles were found missing their labels.
What this means for you
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 by definition is unlikely to cause adverse health consequences. The issue is a packaging/labeling defect (missing label) rather than a contamination or safety hazard.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 17,238 bottles of Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL, NDC 68180-435-01. The recall is due to product complaints indicating that some bottles were missing their labels.
The affected product is Lot # H805157 with an expiration date of 05/2020. The product was distributed nationwide in the U.S. and Puerto Rico. The bottles are manufactured by Lupin Limited in India for Lupin Pharmaceuticals Inc. in Baltimore, Maryland.
Consumers who have this product should check their bottles for missing labels. If a bottle is missing its label, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 17,238
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 (2)
- Lot #: H805157
- Exp. 05/2020
Distribution
Distributed nationwide across the United States.
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