July 2015 FDA Recall Drug by Novartis Pharmaceuticals Corp.
D-1430-2015 - Failed Dissolution Specifications

This Class III drug recall was voluntarily initiated by Novartis Pharmaceuticals Corp. on July 28, 2015 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in NJ - site for distributor and the recall is currently terminated.

Recall Number: D-1430-2015

Reason for Recall
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
Initiated
07-28-2015
Reported
09-23-2015
Quantity
10,767 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71830
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.
NJ - site for distributor
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-10-2017
Product Description About Product Description
Full technical description of the product.
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540

Batch or Lot Expiration Information

Lot# : F0002, Exp 12/2016