Fresenius Kabi Recalls Cisatracurium Vials Due to Labeling Error
Fresenius Kabi is recalling 94,560 vials of Cisatracurium Besylate Injection because the carton labels incorrectly state the product is preservative-free.
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 due to a labeling error regarding preservatives, which fits the rubric criterion for minor labeling errors or low-risk contamination.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 94,560 vials of Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), NDC 63323-417-10. The recall is due to an incorrect statement on the individual carton label that reads "Preservative free." The vial label and the outer carton label correctly state that 0.9% benzyl alcohol is added as a preservative.
The affected product is Lot # 6010157, with an expiration date of 01/2017. The product was distributed nationwide and in Puerto Rico. This is a Class II recall, which the FDA defines as 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.
Healthcare providers and patients should check their inventory for this specific lot number and expiration date. If the product is found, it should be returned to the distributor or the manufacturer. Patients who have already received the medication should contact their healthcare provider if they have questions or concerns.
The recalled product
- Product
- CISATRACURIUM (CISATRACURIUM BESYLATE)
- Brand
- CISATRACURIUM
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 94,560
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 (2)
- Lot #: 6010157
- Exp. 01/2017
UPCs (3)
- 0363323418014
- 0363323416010
- 0363323417017
Distribution
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