Reported Jun 26, 2019 · Terminated
Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-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 0.125 mg1000-count bottleRx only
- Manufactured byCadila Healthcare Ltd Ahmedabad, India
- Distributed byZydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10
- Lot codes and dates
- Lot
M714919EXP Dec-19M815081EXP Aug-20M900475EXP Dec-20
- Lot
- Amount recalled
- 204 1000-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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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