July 2014 FDA Recall Drug by Novartis Pharmaceuticals Corp.
D-1516-2014 - Failed Tablet/Capsule Specifications

This Class III drug recall was voluntarily initiated by Novartis Pharmaceuticals Corp. on July 30, 2014 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1516-2014

Reason for Recall
Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
Initiated
07-30-2014
Reported
08-13-2014
Quantity
50 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68815
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.
Novartis Pharmaceuticals Corp.
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.
12-05-2014
Product Description About Product Description
Full technical description of the product.
Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2.

Batch or Lot Expiration Information

Lot# PKTS, Exp 01/17