Reported Jun 26, 2019 · Terminated
Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd.…
Zydus Pharmaceuticals USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
Pramipexole Dihydrochloride Tablets 0.5 mg90-count bottleRx only
- Manufactured byCadila Healthcare Ltd. Ahmedabad
- India Distributed byZydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 Lots:M713431, M713432, M714172, EXP Sep-19 2 M714173, Oct-19 3 M800552, M800553, M800554, M800555 M800556 EXP Dec-19 4 M811135 M812818 M812819 M812820 M812821 EXP Jun-20, M815777 M815778 M815779 M815780 M815781 EXP Aug-20 5 M901927 M901929 M901931 M901933 M902089 EXP Jan-21 - Amount recalled
- 168,330 90-count bottles
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
This product could cause temporary or reversible health problems — stop using it.
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