Cisplatin Injection Vials Recalled for Failed Impurity and Degradation Standards
Accord Healthcare is recalling 11,214 vials of Cisplatin Injection due to failed impurity and degradation specifications. The recalled lot was distributed nationwide in the United States and Puerto Rico.
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 drug recall of a chemotherapy agent without reported illnesses or injuries. However, failed impurity and degradation specifications in Cisplatin—a potent intravenous cancer treatment—constitutes a risk-of-harm product as defined in the severity rubric for High severity.
Plain-English summary
Accord Healthcare is recalling one lot of Cisplatin Injection, 100 mg/100 mL (1 mg/mL), due to failed impurity and degradation specifications. The affected lot (P2202009, expiration 03/2025) consists of 11,214 vials and was distributed nationwide in the United States and Puerto Rico. Cisplatin is a chemotherapy drug administered by intravenous injection to treat various cancers.
The vials did not meet manufacturing quality standards for chemical impurities and product degradation. This quality defect poses a potential risk to patients who may receive medication that does not meet established safety and efficacy standards.
Accord Healthcare recommends that healthcare providers check their inventory for lot number P2202009 and quarantine any affected vials. Patients should contact their healthcare provider if they have questions about whether they received medication from the recalled lot.
The recalled product
- Product
- CISPLATIN (CISPLATIN)
- Brand
- CISPLATIN
- Manufacturer
- ACCORD HEALTHCARE, INC.
- Hazard
- impurities
- product-degradation
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 (2)
- Lot #: P2202009
- Exp. Date: 03/2025
UPCs (2)
- 0316729288385
- 0316729288118
Distribution
Distributed nationwide across the United States.
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