D-1050-2018 Class III Terminated
FDA drug recall D-1050-2018 was initiated by Lupin Pharmaceuticals Inc. on Jul 26, 2018 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study. The recall status is terminated (terminated Dec 6, 2019). Affected quantity: 13,896 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 8, 2018
- Initiation Date
- Jul 26, 2018
- Termination Date
- Dec 6, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,896 bottles
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
Reason for Recall
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Distribution Pattern
Product was distributed throughout the United States
Code Information
Lot #: H800393, Exp. 01/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1050-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026