February 2015 FDA Recall Drug by Apotex Inc.
D-0487-2015 - CGMP Deviations
This Class III drug recall was voluntarily initiated by Apotex Inc. on February 12, 2015 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0487-2015
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
02-12-2015
04-22-2015
33,795 Bottles
Recall Profile & Regulatory Data
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.
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.
Apotex 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.
U.S. Nationwide.
12-30-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.
Batch or Lot Expiration Information
Lot# a)
Lot# : KY8498, Expiry: 01/2016; b)
Lot# : KY8496, Expiry: 01/2016; c)
Lot# : MC5426, Expiry: 02/2016
Lot# : KZ2002, Expiry: 04/2016.
