Class II · Moderate risk
Spiriva Handihaler
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Spiriva HandiHaler (Tiotropium Bromide)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41 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
Affected NDC
0597-0075-41
Compare with the code on your package — it is the most precise check available.
Drug: Tiotropium
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Spiriva HandiHaler Tiotropium Bromide NDC 00597-0075 |
MONOHYDRATE 18 ug/1 | Capsule Oral|respiratory (inhalation) |
Boehringer Ingelheim Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 0597-0075-41
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0453-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Tiotropium recalls
See all
Class II · Moderate risk
SPIRIVA HandiHaler
Failed Stability Specifications
Class III · Low risk
Spiriva HandiHaler
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.
Class III · Low risk
SPIRIVA HandiHaler
Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler
Other recalls by Cardinal Health Inc.
All 2021 recalls
Class II · Moderate risk
Enoxaparin Sodium Injection
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class II · Moderate risk
Recombinate
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
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