Spiriva HandiHaler recall: CGMP Deviations
Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41…
Why was Spiriva HandiHaler recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
5098
- Product
- Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41…
- Recalling firm
- Cardinal Health Inc.
- Quantity
- 2611 inhalers
- Distribution
- FL, GA, SC
- Recall date
- June 2, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)