Recalls / Class II
Class IID-0114-2017
Product
DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25
- Affected lot / code info
- Lot #: 554820, Exp 5/17
Why it was 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.
Recalling firm
- Firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 900 Ridgebury Rd, Ridgefield, Connecticut 06877-1058
Distribution
- Quantity
- 6400 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-10-06
- FDA classified
- 2016-10-24
- Posted by FDA
- 2016-11-02
- Terminated
- 2017-11-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0114-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.