November 2012 FDA Recall Drug by Boehringer Ingelheim Roxane Inc
D-067-2013 - Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product

This Class II drug recall was voluntarily initiated by Boehringer Ingelheim Roxane Inc on November 5, 2012 for the product Drug. The FDA reported the reason for recall as defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-067-2013

Reason for Recall
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Initiated
11-05-2012
Reported
12-05-2012
Quantity
8,381 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63630
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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 Roxane 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-18-2013
Product Description About Product Description
Full technical description of the product.
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54

Batch or Lot Expiration Information

Lot# Lot 201900 Expiration Date: JAN 2015