FDA recall D-0114-2017

Boehringer Ingelheim Pharmaceuticals, Inc. · Class II · drug

Product

DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25

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-0114-2017