FDA recall D-1432-2019

Product

Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01

Reason for recall

GMP Deviations; possible cross contamination of product due to cleaning procedure failure.

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2019-05-13

Report date

2019-07-03

Termination date

2020-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1432-2019