Reported Jun 26, 2019 · Terminated
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad,…
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 1.5 mg 90-count bottle
- Rx only Manufactured byCadila Healthcare Ltd. Ahmedabad
- India Distributed byZydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16
- Lot codes and dates
- Lots
M713435 M713436 EXP Sep-19M714191 EXP Oct-19M808185 M808184 M808186 EXP May-20M817634 M817635 EXP Nov-20
- Lots
- Amount recalled
- 47,664 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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