FDA recall D-396-2014

Teva Pharmaceuticals USA · Class II · drug

Product

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.

Distribution

Nationwide and Puerto Rico, American Samoa, Virgin Islands, and Canal Zone

Key facts

Status
Terminated
Initiation date
2013-11-26
Report date
2014-01-08
Termination date
2014-08-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-396-2014