Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer In...
FDA Recall #D-0113-2017 — Class II — October 6, 2016
Product Description
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.
Recalling Firm
Boehringer Ingelheim Pharmaceuticals, Inc. — Ridgefield, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2562 bottles
Distribution
Nationwide
Code Information
Lot #:456520, Exp. 5/17
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated