January 2022 FDA Recall Moxifloxacin by Aurobindo Pharma Usa Inc.
D-0560-2022 - Failed Impurities/Degradation Specifications
This Class II drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc. on January 14, 2022 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-0560-2022
Failed Impurities/Degradation Specifications
01-14-2022
02-23-2022
115776 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
07-31-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03
Batch or Lot Expiration Information
Lot# : CMF210001, CMF210003, CMF210004, Exp 6/2023
