February 2019 FDA Recall Moxifloxacin by Lupin Pharmaceuticals Inc.
D-0517-2019 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on February 26, 2019 for the product Moxifloxacin. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0517-2019

Reason for Recall
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Initiated
02-26-2019
Reported
03-06-2019
Quantity
674,628 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82249
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.
06-22-2020
Product Description About Product Description
Full technical description of the product.
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.

Batch or Lot Expiration Information

Lot# Lots: H701618, H701619, H701620, Exp March 2019; H702220, H702221, H702222, H702223, H702224, H702225, H702351, Exp April 2019; H702971, H702972, H702973, H702974, H703151, H703152, H703153, Exp June 2019; H703155, H703682, H703683, Exp July 2019; H704243, H704245, H704247, Exp September 2019; H704707, H704709, H705038, H705039, Exp October 2019; H705561, Exp November 2019; H800394, H800395, H800617, H800618, Exp January 2020; H801585, H801586, H801721, H801722, Exp March 2020; H802138, H802139, H802140, Exp April 2020; H802421, H802707, H802718, Exp May 2020; H803187, H803188, H803232, Exp June 2020; H803749, H803750, Exp July 2020; H804326, H804327, H804328, H804330, H804549, H804552, H804630, H804632, Exp September 2020; H805163, H805361, H805362, H805676, Exp November 2020; H805690, H805692, H805694, Exp December 2020

Affected Packages Involved in this Recall

68180-422-01 Moxifloxacin