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
D-0113-2017
Product summary
- Event
- Event 75374
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2562 bottles
- Official record key
drug-enforcement:D-0113-2017
Official wording
Reason: 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.
Code information: Lot #:456520, Exp. 5/17
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign tablets