Recall: D-0653-2016

Class II - Potentially Harmful

Class IIClassification

2015-12-24Initiated

TerminatedStatus

Macleods Pharma Usa IncFirm

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

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

Distribution

US Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.