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SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose...

FDA Recall #D-0242-2018 — Class II — December 14, 2017

Recall #D-0242-2018 Date: December 14, 2017 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Failed Stability Specifications

Recalling Firm

Boehringer Ingelheim Pharmaceuticals, Inc. — Ridgefield, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

45,008 units/90 capsules each unit

Distribution

Distributed nationwide

Code Information

Lot # 606478; Exp. 03/18

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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