Cardinal Health Recalls Cefazolin Injection Due to Temperature Excursions
Cardinal Health Inc. is recalling Cefazolin for Injection due to intermittent exposure to temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a CGMP deviation (temperature excursion) without reported injuries, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling Cefazolin for Injection, USP 1 gram per vial, manufactured by Sandoz GmbH. The recall is due to CGMP deviations involving intermittent exposure to temperature excursions during storage. The affected product is identified by lot code JZ9830 and NDC 0781-3451-70.
The recalled product was distributed in Florida, Georgia, and South Carolina. It is a prescription-only, sterile, single-use vial intended for intramuscular, intravenous, or parenteral administration.
Consumers and healthcare providers should stop using the affected product and contact Cardinal Health Inc. or their supplier for instructions on return or replacement. No specific illness or injury reports are mentioned in the source text.
The recalled product
- Product
- CEFAZOLIN (CEFAZOLIN)
- Brand
- CEFAZOLIN
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Antibiotic Injection
- Affected units
- 8
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)
- JZ9830
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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