Pramipexole Dihydrochloride Tablet
FDA Recall NDC 33342-033
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Pramipexole Dihydrochloride (NDC 33342-033). A significant event, classified as Class III, was initiated on Aug 21, 2019 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Aug 21, 2019
Sep 18, 2019
1837 90-count bottles
Recall Profile & Regulatory Data
Event ID
83597
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Macleods Pharma Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Jan 28, 2021
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
Batch or Lot Expiration Information
Lot# BPA801A, EXP 12/2020
Affected Packages Involved in this Recall
33342-031-10Product
33342-031-15Product
33342-031-06Product
33342-031-12Product
33342-032-10Product
33342-032-15Product
33342-032-06Product
33342-032-12Product
33342-033-10Product
33342-033-15Product
33342-033-06Product
33342-033-12Product
33342-034-10Product
33342-034-15Product
33342-034-06Product
33342-034-12Product
33342-035-10Product
33342-035-15Product
33342-035-06Product
33342-035-12Product
Class II Terminated
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Dec 24, 2015
Feb 17, 2016
N/A
Recall Profile & Regulatory Data
Event ID
73017
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Macleods Pharma Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Termination Date
Aug 31, 2020
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.
Batch or Lot Expiration Information
Lot# : BPA512A; Expiry: 06/2017.
Affected Packages Involved in this Recall
33342-031-10Product
33342-031-15Product
33342-031-06Product
33342-031-12Product
33342-032-10Product
33342-032-15Product
33342-032-06Product
33342-032-12Product
33342-033-10Product
33342-033-15Product
33342-033-06Product
33342-033-12Product
33342-034-10Product
33342-034-15Product
33342-034-06Product
33342-034-12Product
33342-035-10Product
33342-035-15Product
33342-035-06Product
33342-035-12Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
