D-0114-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 2, 2016
- Initiation Date
- October 6, 2016
- Termination Date
- November 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6400 bottles
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.
Distribution Pattern
Nationwide
Code Information
Lot #: 554820, Exp 5/17