July 2018 FDA Recall Moxifloxacin by Lupin Pharmaceuticals Inc.
D-1050-2018 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on July 26, 2018 for the product Moxifloxacin. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Product was distributed throughout the United States and the recall is currently terminated.

Recall Number: D-1050-2018

Reason for Recall
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Initiated
07-26-2018
Reported
08-08-2018
Quantity
13,896 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80668
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.
Product was distributed throughout the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-06-2019
Product Description About Product Description
Full technical description of the product.
Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01

Batch or Lot Expiration Information

Lot# : H800393, Exp. 01/2020

Affected Packages Involved in this Recall

68180-422-01 Moxifloxacin