Sandoz Inc. recalled 263 vials of Cyclophosphamide injection distributed nationwide in the United States. The recall cites cGMP deviations due to a temperature excursion during transportation. Healthcare providers and patients should stop using the product and contact Sandoz for guidance.
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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Cyclophosphamide is a chemotherapy agent used to treat various cancers. It is supplied in vials for hospital or clinic administration.
A temperature excursion during transport can compromise drug integrity, potentially reducing potency or introducing contaminants in an injectable hazardous drug.
This recall is not described as part of a broader industry pattern in the notice.
Healthcare facilities must identify affected lots and replace or refund through the recall process. No injuries have been reported yet.
NDC numbers on vial and carton labeling; lot number on vial label
Remedy via letter; replacement or refund timelines will be communicated by Sandoz
Keep the recall notice, lot and NDC details, and correspondence with Sandoz for records
Model numbers: Lot # 110459 exp. date 02/28/2027. Quantity: 263 vials. NDCs: Vial NDC 0781-3528-75, Carton NDC 0781-3528-10. Sold nationwide in the USA. Manufacturer: Fareva Unterach GmbH in Austria for Sandoz Inc., Princeton, NJ 08540. Product category: Cyclophosphamide injectable chemotherapy.
No injuries or incidents have been reported in the notice. The recall status remains ACTIVE.
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