November 2015 FDA Recall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate by Teva Pharmaceuticals Usa
D-0566-2016 - Failed Impurities/Degradation Specifications
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on November 12, 2015 for the product Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine 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-0566-2016
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
11-12-2015
01-20-2016
9,717 bottles
Recall Profile & Regulatory Data
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.
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.
Teva Pharmaceuticals USA
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.
Nationwide
11-01-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.
Batch or Lot Expiration Information
Lot# : 34015516A, Exp 05/16
