FDA recall D-0653-2016

Product

Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10.

Reason for recall

Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.

Distribution

US Nationwide.

Key facts

Status

Terminated

Initiation date

2015-12-24

Report date

2016-02-17

Termination date

2020-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0653-2016