Reported Jun 26, 2019 · Terminated

Pramipexole DihydrochlorideTablets 0.125 mg, 90-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

- Pramipexole DihydrochlorideTablets 0.125 mg
- 90-count bottle
- Rx Only
Manufactured byCadila Healthcare Ltd Ahmedabad, India
Distributed byZydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16

Lot codes and dates: 8 of 8 products
Products covered by this recall
# Product as published
1 Lot: M714176, M714177, EXP Oct-19
2 M714917, EXP Nov-19
3 M714918, M715594, M715595, EXP Dec-19
4 M802190, EXP Jan-20
5 M802191, EXP Feb-20, M808673, EXP May-20
6 M811125, M811126, M811127, M811128, M811129, EXP Jun-20
7 M815082, M815083, M815084, M815085, M815086 EXP Aug-20
8 M900476, M900477, M900478, M900479, M900481, Dec-20
Amount recalled: 143,184 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.