Why it was recalled
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Product description
Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61.
Lot numbers, UPCs & expiration codes
Lot # AA3280A, Exp SEP 2019
Where it was sold
Nationwide in the USA
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-0991-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 7, 2019
- FDA report date
- Mar 20, 2019
- Quantity
- 112 folding cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0991-2019, exactly as published.
Show all FDA fields
- City
- Ridgefield
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 82310
- Address
- 900 Ridgebury Rd
- Code information
- Lot # AA3280A, Exp SEP 2019
- Postal code
- 06877-1058
- Report date
- Mar 20, 2019
- Product type
- Drugs
- Recall number
- D-0991-2019
- Classification
- Class III
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Product quantity
- 112 folding cartons
- Termination date
- Sep 11, 2019
- Reason for recall
- Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 7, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 11, 2019