FDA recall D-0517-2019

Lupin Pharmaceuticals Inc. · Class III · drug

Product

Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.

Reason for recall

Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.

Distribution

Nationwide in the USA and Puerto Rico.

Key facts

Status
Terminated
Initiation date
2019-02-26
Report date
2019-03-06
Termination date
2020-06-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0517-2019