FDA recall D-1116-2015

Product

Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.

Reason for recall

Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.

Distribution

United States Nationwide

Key facts

Status

Terminated

Initiation date

2015-04-17

Report date

2015-06-17

Termination date

2016-04-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1116-2015