Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods ...
FDA Recall #D-0653-2016 — Class II — December 24, 2015
Product Description
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.
Recalling Firm
Macleods Pharma Usa Inc — Plainsboro, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
US Nationwide.
Code Information
Lot #: BPA512A; Expiry: 06/2017.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated