Fresenius Kabi Recalls Dexmedetomidine Injection Due to Lidocaine Contamination
Fresenius Kabi is recalling 13,525 bottles of Dexmedetomidine HCl Injection due to cross-contamination with trace amounts of lidocaine.
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 per the rubric mandates a minimum severity score of 4 (Severe).
Plain-English summary
Fresenius Kabi USA, LLC is recalling 13,525 bottles of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle. The product is identified by NDC 63323-671-05 and Lot # 6123925. The recall was initiated because the product was found to contain trace amounts of lidocaine due to cross-contamination with other products.
The affected product was distributed nationwide in the United States. Dexmedetomidine is a prescription medication used for sedation. The presence of lidocaine, an anesthetic, in this injection is an unintended contamination that may pose a risk to patients.
Healthcare providers and patients should check their inventory for the specific lot number and NDC listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have received this medication should contact their healthcare provider for guidance.
The recalled product
- Product
- Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 13,525
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 #: 6123925
Distribution
Distributed nationwide across the United States.
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