Sandoz Inc. recalled 263 vials of Cyclophosphamide Injection on September 5, 2025. The recall follows cGMP deviations related to temperature excursions during transportation. Healthcare providers and consumers must stop using the product immediately.
cGMP deviations: Temperature excursion during transportation.
Consumers and healthcare providers should stop using this product immediately. Contact Sandoz Inc or your healthcare provider for guidance. Notification method: Letter
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The recalled product is Cyclophosphamide Injection 500 mg/5 mL, Lot # 110459, with an expiration date of February 28, 2027. It is manufactured in Austria by Fareva Unterach GmbH. The product is distributed nationwide in the USA.
The recall is due to cGMP deviations, specifically temperature excursions that could compromise product integrity. These issues pose a significant risk to patient safety.
No specific incidents or injuries have been reported related to this recall. The recall is precautionary based on manufacturing deviations.
Stop using the recalled product immediately. Contact Sandoz Inc. or your healthcare provider for further guidance.
For more information, contact Sandoz Inc. at their official website or through the recall notification letter.
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