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.
Reported: July 24, 2019 Initiated: July 11, 2019 #D-1490-2019
Product Description
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.
Reason for Recall
Labeling: Missing label; Product complaints reported missing bottle label.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 17,238 bottles
- Distribution
- Nationwide in the U.S. and PR.
- Location
- Baltimore, MD
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 for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 17,238 bottles.
Why was this product recalled? ▼
Labeling: Missing label; Product complaints reported missing bottle label.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 24, 2019. Severity: Low. Recall number: D-1490-2019.
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