Teva Recalls MitoXANTRONE Injection Due to Potential Impurity D Failure
Teva Pharmaceuticals USA is recalling MitoXANTRONE Injection USP vials nationwide because they may fail to meet specifications for Impurity D throughout their shelf life.
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 recall is classified as FDA Class III, 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 Pharmaceuticals USA is recalling 11,214 vials of MitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial. The product is distributed nationwide and is available by prescription only. The recall involves specific lot numbers with expiration dates ranging from September 2016 to February 2018.
The recall was initiated because the product may fail to meet the specification for Impurity D throughout its shelf life. This is a potential quality control issue regarding chemical degradation or impurities in the medication.
Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the manufacturer for further instructions. The recall is classified as Class III by the FDA, indicating that the product is unlikely 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, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 11,214
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 (10)
- Lot Numbers: 31318574B
- Exp 09/16
- 31319610B
- Exp 07/17
- 31320058B
- Exp 11/17
- 31320497B
- Exp 12/17
- 31320744B
- Exp 02/18
Distribution
Distributed nationwide across the United States.
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