Cardinal Health Recalls Cyanocobalamin Injection Due to Temperature Excursions
Cardinal Health Inc. is recalling 6 boxes of Cyanocobal Injection 1000mcg/mL 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 potential loss of potency due to temperature excursions without reported injuries, fitting the criteria for moderate severity.
Plain-English summary
Cardinal Health Inc. is recalling 6 boxes of Cyanocobal Injection 1000mcg/mL (NDC 69680-112-25). The product is a multi-dose vial intended for intramuscular use. The recall was initiated due to CGMP deviations involving intermittent exposure to temperature excursions during storage.
The affected product was distributed to Florida, Georgia, and South Carolina. The specific lot code for the recalled items is 303824. No illnesses or injuries have been reported in connection with this recall.
Healthcare providers and patients should stop using the affected product and contact Cardinal Health Inc. for further instructions or a replacement.
The recalled product
- Product
- CYANOCOBALAMIN (CYANOCOBALAMIN)
- Brand
- CYANOCOBALAMIN
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Injection
- Affected units
- 6
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)
- 303824
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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