February 2017 FDA Recall Drug by Actavis Inc
D-0514-2017 - Failed Impurities/ Degradation Specifications

This Class III drug recall was voluntarily initiated by Actavis Inc on February 7, 2017 for the product Drug. 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-0514-2017

Reason for Recall
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Initiated
02-07-2017
Reported
03-15-2017
Quantity
14280 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76421
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.
Actavis 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-09-2018
Product Description About Product Description
Full technical description of the product.
Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05

Batch or Lot Expiration Information

Lot# 348748, Exp 11/30/2017; 350578, Exp 3/31/2018; 633467, Exp 3/31/2017