Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Product description
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01
Lot numbers, UPCs & expiration codes
Lot Numbers: H705562, H705563, EXP. 11/2019; H800616, EXP. 01/2020
Where it was sold
Product was distributed by 5 wholesalers, 6 drug chains, 4 mail order pharmacies and 1 mail order pharmacy/supermarket who may have further distribute the product throughout the United States.
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-0484-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 1, 2019
- FDA report date
- Feb 20, 2019
- Quantity
- 43,860 3ml bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0484-2019, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 82037
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Lot Numbers: H705562, H705563, EXP. 11/2019; H800616, EXP. 01/2020
- Postal code
- 21202-6174
- Report date
- Feb 20, 2019
- Product type
- Drugs
- Recall number
- D-0484-2019
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 43,860 3ml bottles
- Termination date
- Jun 26, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01
- Distribution pattern
- Product was distributed by 5 wholesalers, 6 drug chains, 4 mail order pharmacies and 1 mail order pharmacy/supermarket who may have further distribute the product throughout the United States.
- Recall initiation date
- Feb 1, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 8, 2019