Why it was recalled
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Product description
Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
Lot numbers, UPCs & expiration codes
Lot #: 29906202, Exp 12/18; 29993102, Exp 2/19; 30366102, 30373103, Exp 4/19; 31940601, Exp 3/20.
Where it was sold
United States 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-1185-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 6, 2018
- FDA report date
- Sep 19, 2018
- Quantity
- 16,207 (bottles of 30 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Par Pharmaceutical, Inc.
Original FDA data
Every field from FDA enforcement report D-1185-2018, exactly as published.
Show all FDA fields
- City
- Chestnut Ridge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 80969
- Address
- 1 Ram Ridge Rd
- Code information
- Lot #: 29906202, Exp 12/18; 29993102, Exp 2/19; 30366102, 30373103, Exp 4/19; 31940601, Exp 3/20.
- Postal code
- 10977-6714
- Report date
- Sep 19, 2018
- Product type
- Drugs
- Recall number
- D-1185-2018
- Classification
- Class III
- Recalling firm
- Par Pharmaceutical, Inc.
- Product quantity
- 16,207 (bottles of 30 tablets)
- Termination date
- Dec 6, 2019
- Reason for recall
- Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
- Distribution pattern
- United States nationwide
- Recall initiation date
- Sep 6, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 10, 2018