December 2017 FDA Recall Spiriva by Boehringer Ingelheim Pharmaceuticals, Inc.
D-0242-2018 - Failed Stability Specifications

This Class II drug recall was voluntarily initiated by Boehringer Ingelheim Pharmaceuticals, Inc. on December 14, 2017 for the product Spiriva. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0242-2018

Reason for Recall
Failed Stability Specifications
Initiated
12-14-2017
Reported
02-07-2018
Quantity
45,008 units/90 capsules each unit

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78775
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 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.
Distributed nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-17-2018
Product Description About Product Description
Full technical description of the product.
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47

Batch or Lot Expiration Information

Lot# 606478; Exp. 03/18

Affected Packages Involved in this Recall

0597-0075-41 Spiriva Handihaler
0597-0075-75 Spiriva Handihaler
0597-0075-47 Spiriva Handihaler