March 2014 FDA Recall Spiriva by Boehringer Ingelheim Roxane Inc
D-1230-2014 - Defective Delivery System

This Class III drug recall was voluntarily initiated by Boehringer Ingelheim Roxane Inc on March 27, 2014 for the product Spiriva. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1230-2014

Reason for Recall
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
Initiated
03-27-2014
Reported
04-16-2014
Quantity
1,276,710 Blister Cards

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67796
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 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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-26-2015
Product Description About Product Description
Full technical description of the product.
Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany, Marketed by: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA and Pfizer Inc New York, NY 10017 USA, Made in Germany.

Batch or Lot Expiration Information

Lot# a) 5 count capsule blister card: 303012A, Exp Sep 2014; b) 30 count capsules blister card: 303012B, Exp Sep 2014, 303125A, 303253A, Exp Oct 2014, 303895A, 304282A, Exp Nov 2014, 304510A, Exp Dec 2014

Affected Packages Involved in this Recall

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