FDAFDA · Food and drugs·Recall number D-1490-2019
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.
Published July 24, 2019 · Recall initiated: July 11, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Missing label; Product complaints reported missing bottle label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Nationwide in the U.S. and PR.
- Lot
- Lot #: H805157, Exp. 05/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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