PlainRecalls
FDA Drug Moderate Class II Terminated

Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98

Reported: January 8, 2014 Initiated: November 26, 2013 #D-396-2014

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.

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
10,512 bottles
Distribution
Nationwide and Puerto Rico, American Samoa, Virgin Islands, and Canal Zone
Location
Horsham, PA

Frequently Asked Questions

What product was recalled?
Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98. Recalled by Teva Pharmaceuticals USA. Units affected: 10,512 bottles.
Why was this product recalled?
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 8, 2014. Severity: Moderate. Recall number: D-396-2014.