Home / Recalls / Macleods Pharma Usa Inc / D-1851-2019

D-1851-2019 Class III Terminated

Recalled by Macleods Pharma Usa Inc — Plainsboro, NJ

Recall Details

Product Type
Drugs
Report Date
September 18, 2019
Initiation Date
August 21, 2019
Termination Date
January 28, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1837 90-count bottles

Product Description

Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10

Reason for Recall

Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lot #BPA801A, EXP 12/2020

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