American Health Packaging recalls Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American…

Recall date

May 13, 2019

Source

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

Recall number

D-1433-2019

FDA classification

Class II

Brand / firm

American Health Packaging

Sold / distributed

Nationwide USA

Why it was recalled

GMP Deviations; possible cross contamination of product due to cleaning procedure 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, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-974-95; NDC Carton: 68084-974-25