PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: November 2, 2016 Initiated: October 6, 2016 #D-0114-2017

Product Description

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.

Details

Units Affected
6400 bottles
Distribution
Nationwide
Location
Ridgefield, CT

Frequently Asked Questions

What product was recalled?
DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25. Recalled by Boehringer Ingelheim Pharmaceuticals, Inc.. Units affected: 6400 bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 2, 2016. Severity: Moderate. Recall number: D-0114-2017.