Pramipexole Dihydrochoride Tablets 0 recalled over manufacturing violations

Recall date

May 6, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Zydus Pharmaceuticals USA Inc recalls Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad,…

Recall number

D-1444-2019

FDA classification

Class II

Brand / firm

Zydus Pharmaceuticals USA Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16