Cardinal Health Recalls Methotrexate Injection Due to Temperature Excursions
Cardinal Health Inc. is recalling 341 vials of Methotrexate Injection due to intermittent exposure to temperature excursions during storage.
What this means for you
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: The recall is classified as FDA Class II, and the hazard involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 341 vials of Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials. The product is distributed by Hospira, Inc. and carries the NDC 61703-350-38. The recall was initiated due to CGMP deviations involving intermittent exposure to temperature excursions during storage.
The affected product was distributed in Florida, Georgia, and South Carolina. The specific lot code for the recalled vials is H074437AA. Methotrexate is a prescription medication used for various medical conditions, and the temperature excursions may affect the stability or efficacy of the drug.
Healthcare providers and patients should check their inventory for the specific NDC and lot code listed above. If the product is found, it should be quarantined and not administered. Patients who have already received the medication should contact their healthcare provider for guidance.
The recalled product
- Product
- METHOTREXATE (METHOTREXATE)
- Brand
- METHOTREXATE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Injection
- Affected units
- 341
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 (1)
- H074437AA
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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