November 2013 FDA Recall Drug by Teva Pharmaceuticals Usa
D-396-2014 - Failed Tablet/Capsule Specifications
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on November 26, 2013 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-396-2014
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
11-26-2013
01-08-2014
10,512 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 and Puerto Rico, American Samoa, Virgin Islands, and Canal Zone
08-27-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98
Batch or Lot Expiration Information
Lot# : 32900349B, Exp: 12/2014
