Reported Jun 26, 2019 · Terminated
Pramipexole Dihydrochoride Tablets 0.25 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 Dihydrochoride Tablets 0.25 mg90-count bottleRx Only
- Manufactured byCadila Healthcare Ltd Ahmedabad
- India Distributed byZydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 M706802, M706804, M706907, M706909, M707028, EXP May-19 2 M714180, M714181, EXP Oct-19 3 M717063, M717064, M801705, M801706, M801707, M801708, M714923, M714924, M714925 EXP Dec-19 4 M808307, M808308, M808309, M808310, EXP May-20 5 M812479, M812481, M812482, M812483, EXP Jul-20 6 M815787 M815789, M815790, M815791, M815788, EXP Sep-20 7 M820266, M820267, M820268, M820269, M820265 EXP Nov-20 8 M903040, M903041, M903042 EXP Jan-21. - Amount recalled
- 215,760 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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