Why it was recalled
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Product description
Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01
Lot numbers, UPCs & expiration codes
Lot #: H800393, Exp. 01/2020
Where it was sold
Product was distributed 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-1050-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 26, 2018
- FDA report date
- Aug 8, 2018
- Quantity
- 13,896 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1050-2018, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 80668
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Lot #: H800393, Exp. 01/2020
- Postal code
- 21202-6174
- Report date
- Aug 8, 2018
- Product type
- Drugs
- Recall number
- D-1050-2018
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 13,896 bottles
- Termination date
- Dec 6, 2019
- Reason for recall
- Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01
- Distribution pattern
- Product was distributed throughout the United States
- Recall initiation date
- Jul 26, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 8, 2018