Fresenius Kabi Recalls Mislabelled Midazolam Syringes Containing Ondansetron
Fresenius Kabi is recalling 203,136 syringes of Midazolam Injection that were mislabeled and actually contain Ondansetron Injection.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 203,136 syringes of Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL). The product is packaged in 24 x 2 mL prefilled single-use syringes per carton and is distributed nationwide in the USA. The specific lot number is 6400048.
The recall was initiated due to a labeling mix-up. The blister packages are labeled as Midazolam Injection, USP, 2 mg / 2 mL, but they actually contain syringes of Ondansetron Injection, USP, 4 mg / 2 mL. This discrepancy means that healthcare providers or patients relying on the label may administer the wrong medication.
Healthcare facilities and consumers who have this product should stop using it and contact Fresenius Kabi USA, LLC for instructions on how to return the product. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE)
- Brand
- MIDAZOLAM
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injection
- Affected units
- 203,136
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)
- Lot: 6400048
Distribution
Distributed nationwide across the United States.
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Similar recalls
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