March 2019 FDA Recall Drug by Boehringer Ingelheim Pharmaceuticals, Inc.
D-0991-2019 - Failed Tablet/Capsule Specifications

This Class III drug recall was voluntarily initiated by Boehringer Ingelheim Pharmaceuticals, Inc. on March 7, 2019 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0991-2019

Reason for Recall
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Initiated
03-07-2019
Reported
03-20-2019
Quantity
112 folding cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82310
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Boehringer Ingelheim Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2019
Product Description About Product Description
Full technical description of the product.
Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61.

Batch or Lot Expiration Information

Lot# AA3280A, Exp SEP 2019