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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zydus Pharmaceuticals USA Inc
- Reason for Recall:
- CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1446-2019
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