FDA recall D-1112-2015

Product

Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01

Reason for recall

Failed Dissolution Specifications: OOS result during stability testing

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-05-11

Report date

2015-06-10

Termination date

2016-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1112-2015