Why it was recalled
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Product description
Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16
Lot numbers, UPCs & expiration codes
Lots:M713431, M713432, M714172, EXP Sep-19; M714173, Oct-19; M800552, M800553, M800554, M800555 M800556 EXP Dec-19; M811135 M812818 M812819 M812820 M812821 EXP Jun-20, M815777 M815778 M815779 M815780 M815781 EXP Aug-20; M901927 M901929 M901931 M901933 M902089 EXP Jan-21
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-1446-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 6, 2019
- FDA report date
- Jun 26, 2019
- Quantity
- 168,330 90-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-1446-2019, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82827
- Address
- 73 Route 31 N
- Code information
- Lots:M713431, M713432, M714172, EXP Sep-19; M714173, Oct-19; M800552, M800553, M800554, M800555 M800556 EXP Dec-19; M811135 M812818 M812819 M812820 M812821 EXP Jun-20, M815777 M815778 M815779 M815780 M815781 EXP Aug-20; M901927 M901929 M901931 M901933 M902089 EXP Jan-21
- Postal code
- 08534-3601
- Report date
- Jun 26, 2019
- Product type
- Drugs
- Recall number
- D-1446-2019
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 168,330 90-count bottles
- Termination date
- Sep 16, 2021
- Reason for recall
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 6, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 1, 2019