Cardinal Health Recalls Cathflo Activase Due to Temperature Excursions
Cardinal Health is recalling 1,473 vials of Cathflo Activase (alteplase) 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 source text does not report any illnesses, injuries, or fatalities, fitting the criteria for a moderate severity score involving potential but unreported harm.
Plain-English summary
Cardinal Health Inc. is recalling 1,473 vials of CATHFLO ACTIVASE (ALTEPLASE) 2 mg. The product is a prescription-only intravenous medication manufactured by Genentech, Inc. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product is identified by NDC 50242-041-64 and code 3410425. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product was distributed to facilities in Florida, Georgia, and South Carolina. Consumers and healthcare providers should check their inventory for the specific NDC and code listed above. If the product is found, it should be quarantined and not administered. Recipients should contact Cardinal Health Inc. for further instructions on the return or disposal of the affected units.
The recalled product
- Product
- CATHFLO ACTIVASE (ALTEPLASE)
- Brand
- CATHFLO ACTIVASE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 1,473
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)
- 3410425
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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