May 2014 FDA Recall Dextroamphetamine Sulfate by Teva Pharmaceuticals Usa
D-1408-2014 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on May 1, 2014 for the product Dextroamphetamine Sulfate. 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-1408-2014

Reason for Recall
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
Initiated
05-01-2014
Reported
07-02-2014
Quantity
9,882 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68225
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.
Teva Pharmaceuticals USA
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.
12-09-2014
Product Description About Product Description
Full technical description of the product.
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.

Batch or Lot Expiration Information

Lot# 34013122A, Exp 11/15

Affected Packages Involved in this Recall

0555-0952-02 Dextroamphetamine Sulfate
0555-0953-02 Dextroamphetamine Sulfate