April 2012 FDA Recall Drug by Apotex Inc.
D-1439-2012 - Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by Apotex Inc. on April 30, 2012 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1439-2012

Reason for Recall
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
Initiated
04-30-2012
Reported
08-08-2012
Quantity
119,794 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62574
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.
Apotex 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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-19-2013
Product Description About Product Description
Full technical description of the product.
Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9

Batch or Lot Expiration Information

Lot# s: JN1060, JN1061, JN1062, Exp 06/12