Prescription Inhalation Powder Recalled for Storage Temperature Deviation
Cardinal Healthcare recalls batch 62002532 of Wixela Inhub inhalation powder nationwide due to CGMP deviations. Products were exposed to temperatures outside labeled storage conditions, potentially affecting product stability.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II manufacturing deviation involving temperature exposure on a prescription respiratory medication. While no illnesses or injuries have been reported, temperature deviation may compromise drug stability and efficacy in a risk-of-harm product.
Plain-English summary
Cardinal Healthcare is recalling batch 62002532 of Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, 500/50 mcg) manufactured for Mylan Pharmaceuticals Inc. The recall is due to manufacturing (CGMP) deviations. Products in this batch were exposed to temperatures outside the labeled storage conditions.
Wixela Inhub is distributed nationwide as a prescription inhalation medication. Temperature exposure outside specified storage conditions may affect the stability and efficacy of the product.
Patients currently using this recalled batch should contact their healthcare provider or pharmacist. Do not discontinue use without medical guidance. Your healthcare provider can verify whether you have the affected batch and provide appropriate guidance or a replacement as needed.
The recalled product
- Product
- WIXELA INHUB (FLUTICASONE PROPIONATE AND SALMETEROL)
- Brand
- WIXELA INHUB
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Prescription Inhalation
- Hazard
- storage-temperature-deviation
- product-stability-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch 62002532
Distribution
Distributed nationwide across the United States.
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