Why it was recalled
Labeling: Missing label; Product complaints reported missing bottle label.
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.
Lot numbers, UPCs & expiration codes
Lot #: H805157, Exp. 05/2020
Where it was sold
Nationwide in the U.S. and PR.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1490-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 11, 2019
- FDA report date
- Jul 24, 2019
- Quantity
- 17,238 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1490-2019, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 83333
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Lot #: H805157, Exp. 05/2020
- Postal code
- 21202-6174
- Report date
- Jul 24, 2019
- Product type
- Drugs
- Recall number
- D-1490-2019
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 17,238 bottles
- Termination date
- Sep 9, 2020
- Reason for recall
- Labeling: Missing label; Product complaints reported missing bottle label.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the U.S. and PR.
- Recall initiation date
- Jul 11, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2019