FDA recall D-0326-2022

Lupin Pharmaceuticals Inc. · Class III · drug

Product

Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.

Reason for recall

Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2021-12-22
Report date: 2022-01-12
Termination date: 2022-09-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0326-2022