Pramipexole Dihydrochloride 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 Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad…

Recall number

D-1446-2019

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 Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16