Drug product
DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25
D-0114-2017
Product summary
- Event
- Event 75374
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6400 bottles
- Official record key
drug-enforcement:D-0114-2017
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 #: 554820, Exp 5/17
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign tablets