Recalls / Class II
Class IID-0113-2017
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
- Affected lot / code info
- Lot #:456520, 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
- 2562 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-0113-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.