Fresenius Kabi Recalls Dexmedetomidine Injection Due to Lidocaine Contamination
Fresenius Kabi is recalling specific lots of Dexmedetomidine HCl Injection due to trace amounts of lidocaine contamination.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric, as it poses a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 25,100 bottles of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only. The product is identified by NDC 63323-671-05.
The recall is being conducted because the product was found to contain trace amounts of lidocaine, a different medication, due to cross-contamination. The affected lots are 6121853 (Exp 05/2021) and 6122207 (Exp 06/2021). The product was distributed nationwide in the U.S.A.
Healthcare providers and patients should check their inventory and medication records for these specific lot numbers. If you have this product, do not use it and contact your healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable
- Affected units
- 25,100
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 (4)
- Lot #: 6121853
- Exp 05/2021
- 6122207
- Exp 06/2021
Distribution
Distributed nationwide across the United States.
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