Albuterol Sulfate Inhaler Recalled Due to Temperature Storage Deviation
Cardinal Healthcare is recalling Albuterol Sulfate inhalers (Batch K100715) due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions. Approximately 11 cartons were distributed nationwide. Contact your pharmacist or doctor for a replacement.
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 recall involving a rescue medication exposed to storage temperatures outside labeled conditions. No injuries or illnesses have been reported. Per the rubric, this qualifies as a risk-of-harm product without reported injury, warranting a High severity score.
Plain-English summary
Cardinal Healthcare is recalling Albuterol Sulfate inhalers manufactured by Lupin Pharmaceuticals, Inc. The recalled product is a prescription inhaler containing 90 mcg albuterol sulfate per actuation with 200 metered inhalations per unit (NDC 68180-963-01). This recall affects approximately 11 cartons of Batch K100715.
The recall was initiated due to CGMP deviations. Products in this batch were exposed to temperatures outside the labeled storage conditions.
The inhalers were distributed nationwide throughout the United States.
Patients who have this product should contact their pharmacist or healthcare provider for a replacement inhaler. Do not discontinue use of your rescue medication without medical guidance.
The recalled product
- Product
- ALBUTEROL SULFATE (ALBUTEROL SULFATE)
- Brand
- ALBUTEROL SULFATE
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Inhalation aerosol
- Hazard
- temperature-exposure
- storage-condition-deviation
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 K100715
UPCs (1)
- 0368180963011
Distribution
Distributed nationwide across the United States.
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