February 2022 FDA Recall Drug by Direct Rx
D-0637-2022 - Failed impurities/degradation specifications

This Class II drug recall was voluntarily initiated by Direct Rx on February 17, 2022 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Florida and the recall is currently terminated.

Recall Number: D-0637-2022

Reason for Recall
Failed impurities/degradation specifications
Initiated
02-17-2022
Reported
03-09-2022
Quantity
44 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89642
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Direct Rx
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.
Florida
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-04-2023
Product Description About Product Description
Full technical description of the product.
Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05

Batch or Lot Expiration Information

Lot# : 18JA2218 Exp. 6/30/23; 20DE2104 Exp. 6/30/23; 08NO2111 Exp. 6/30/23