FDA recall D-0113-2017

Boehringer Ingelheim Pharmaceuticals, Inc. · Class II · drug

Product

Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0019-01

Reason for recall

Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2016-10-06
Report date: 2016-11-02
Termination date: 2017-11-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Ridgefield, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0113-2017