FDA-Drug2016-11-02Class II

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

Boehringer Ingelheim Pharmaceuticals, Inc.
Hazard

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.

Sold states
Nationwide
Affected count
6400 bottles
Manufactured in
900 Ridgebury Rd, Ridgefield, CT, United States
Products
DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0114-2017

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