December 2021 FDA Recall Drug by Lupin Pharmaceuticals Inc.
D-0326-2022 - Failed Stability Specifications

This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on December 22, 2021 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0326-2022

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.
Initiated
12-22-2021
Reported
01-12-2022
Quantity
50,832 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89268
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-12-2022
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : H003037, exp. date May 2022; H100132, exp. date June 2022; H100847, exp. date October 2022