August 2019 FDA Recall Pramipexole Dihydrochloride by Macleods Pharma Usa Inc
D-1851-2019 - Subpotent Drug
This Class III drug recall was voluntarily initiated by Macleods Pharma Usa Inc on August 21, 2019 for the product Pramipexole Dihydrochloride. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1851-2019
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
08-21-2019
09-18-2019
1837 90-count bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Macleods Pharma Usa Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the USA
01-28-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
