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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #:456520, Exp. 5/17
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0113-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 6, 2016
- FDA report date
- Nov 2, 2016
- Quantity
- 2562 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0113-2017, exactly as published.
Show all FDA fields
- City
- Ridgefield
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 75374
- Address
- 900 Ridgebury Rd
- Code information
- Lot #:456520, Exp. 5/17
- Postal code
- 06877-1058
- Report date
- Nov 2, 2016
- Product type
- Drugs
- Recall number
- D-0113-2017
- Classification
- Class II
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Product quantity
- 2562 bottles
- Termination date
- Nov 29, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 6, 2016
- Initial firm notification
- Letter
- Center classification date
- Oct 24, 2016