Cyclophosphamide injection vials recalled after a transportation temperature excursion
Six vials of Sandoz Cyclophosphamide Injection 500 mg/5 mL from lot 110459 are recalled nationwide after a temperature excursion during transportation.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the notice states a transportation temperature excursion without describing any consequence to the product.
Plain-English summary
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), a hazardous drug supplied sterile in 5 mL multiple dose vials on prescription only, manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc. of Princeton, New Jersey, vial NDC 0781-3528-75, is being recalled. The recall covers 6 vials identified by specific GTIN numbers within lot 110459, which expires 02/28/2027, distributed nationwide.
The recall follows current good manufacturing practice deviations: a temperature excursion during transportation. The FDA classified the action as Class II.
Pharmacies holding the affected vials should quarantine them and follow Sandoz's instructions for return or replacement.
The recalled product
- Product
- CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE)
- Brand
- CYCLOPHOSPHAMIDE
- Manufacturer
- Sandoz Inc
- Category
- Drug — Oncology
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 106872814353
Distribution
Distributed nationwide across the United States.
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