July 2019 FDA Recall Drug by Lupin Pharmaceuticals Inc.
D-1490-2019 - Labeling

This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on July 11, 2019 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1490-2019

Reason for Recall
Labeling: Missing label; Product complaints reported missing bottle label.
Initiated
07-11-2019
Reported
07-24-2019
Quantity
17,238 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83333
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 U.S. and PR.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-09-2020
Product Description About Product Description
Full technical description of the product.
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.

Batch or Lot Expiration Information

Lot# : H805157, Exp. 05/2020