Recalls / Class III
Class IIID-1490-2019
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.
- Affected lot / code info
- Lot #: H805157, Exp. 05/2020
Why it was recalled
Labeling: Missing label; Product complaints reported missing bottle label.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 17,238 bottles
- Distribution pattern
- Nationwide in the U.S. and PR.
Timeline
- Recall initiated
- 2019-07-11
- FDA classified
- 2019-07-17
- Posted by FDA
- 2019-07-24
- Terminated
- 2020-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1490-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.