Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA,...
FDA Recall #D-396-2014 — Class II — November 26, 2013
Product Description
Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98
Reason for Recall
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Recalling Firm
Teva Pharmaceuticals USA — Horsham, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
10,512 bottles
Distribution
Nationwide and Puerto Rico, American Samoa, Virgin Islands, and Canal Zone
Code Information
Lot#: 32900349B, Exp: 12/2014
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated