Cardinal Health Recalls Invega Sustenna Syringes Due to Temperature Excursions
Cardinal Health is recalling 534 syringes of Invega Sustenna 156mg/1ml due to intermittent exposure to temperature excursions during storage.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 deaths. The hazard is a theoretical risk related to storage conditions (temperature excursion) rather than a confirmed contamination or defect causing harm, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported adverse events.
Plain-English summary
Cardinal Health Inc. is recalling 534 syringes of INVEGA SUSTENNA 156MG/1ML (NDC/UPC 50458056301) due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage.
The affected product is identified by the code KIB0M00. The recall covers syringes distributed 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 removed from use and returned to the supplier or disposed of according to local regulations. No specific instructions for patient management are provided in the source text.
The recalled product
- Product
- INVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGES
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Antipsychotic
- Affected units
- 534
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)
- KIB0M00
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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