Teva Recalls MitoXANTRONE Injection Due to High Impurity Levels
Teva North America is recalling 2,506 vials of MitoXANTRONE Injection USP because high levels of Impurity D were detected.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Teva North America is recalling 2,506 vials of MitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial. The product is identified by Lot # 31318659B and has an expiration date of 02/17. The recall was initiated because the product failed impurities and degradation specifications, specifically showing high out-of-specification results for Impurity D.
The affected product was distributed nationwide. MitoXANTRONE Injection is a prescription-only medication. The source text does not specify the exact number of patients affected or report any specific illnesses or injuries associated with this recall.
Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class III, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
- Manufacturer
- Teva North America
- Category
- Drug — Injectable
- Hazard
- Affected units
- 2,506
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 # 31318659B
- Exp 02/17
Distribution
Distributed nationwide across the United States.
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