Drug recall D-1050-2018
Product
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
Reason for recall
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Lots and codes
Lot #: H800393, Exp. 01/2020
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 13,896 bottles
- Distribution
- Product was distributed throughout the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 26, 2018
- Terminated
- December 6, 2019
Related products
- Moxifloxacin – drug information
- NDC 68180-422 Moxifloxacin · Moxifloxacin Hydrochloride Monohydrate 5 mg/mL · Lupin Pharmaceuticals, Inc.