Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, P...
FDA Recall #D-0326-2022 — Class III — December 22, 2021
Product Description
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.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
50,832 bottles
Distribution
Nationwide in the USA and Puerto Rico
Code Information
Lot #: H003037, exp. date May 2022; H100132, exp. date June 2022; H100847, exp. date October 2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated