Reported Jun 26, 2019 · Terminated
Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-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 0.25 mg1000-count bottleRx only
- Manufactured byCadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10
- Lot codes and dates
- Lots
M706803EXP Jun-19M713438EXP Oct-19M801704EXP Jan-20M808306EXP Jun-20M812484EXP Aug-20M820264EXP Dec-20
- Lots
- Amount recalled
- 3,156 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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