Reported Jun 26, 2019 · Terminated

Pramipexole Dihydrochloride Tablets 1 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

- Pramipexole Dihydrochloride Tablets 1 mg
- 90-count bottle
- Rx only
Manufactured byCadila Healthcare Ltd Ahmedabad
India Distributed byZydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16

Lot codes and dates: 6 of 6 products
Products covered by this recall
# Product as published
1 M714186 M714187 M714188 EXP Oct-19
2 M714903 M714904 M714905 M715586 M715587 EXP Nov-19
3 M801441 M801442 M801443 M801444 M801445 EXP Dec-19
4 M811152 M811153 M811154 M811155 M811156 M814298 EXP Jul-20
5 M814299 M814300 M814301 M814302 EXP Aug-20
6 M818136 M818137 M818138 M818139 M818140 EXP Nov-20
Amount recalled: 113,304 90-count bottles

The agency filed one notice per product. You are reading one of them; the other 13 are below.

1 more are in the archive.

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

This product could cause temporary or reversible health problems — stop using it.

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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23 in total.