D-0484-2019 Class III Terminated
FDA drug recall D-0484-2019 was initiated by Lupin Pharmaceuticals Inc. on February 1, 2019 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained. The recall status is terminated (terminated June 26, 2020). Affected quantity: 43,860 3ml bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 20, 2019
- Initiation Date
- February 1, 2019
- Termination Date
- June 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43,860 3ml bottles
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
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
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.
Code Information
Lot Numbers: H705562, H705563, EXP. 11/2019; H800616, EXP. 01/2020