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.

Recall Number: D-0653-2016

Firm: Macleods Pharma Usa Inc

Classification: Class II

Status: Terminated

Report Date: 20160217

Initiation Date: 20151224

Termination Date: 20200831

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

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.