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Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single...

FDA Recall #D-0120-2021 — Class I — November 17, 2020

Recall #D-0120-2021 Date: November 17, 2020 Classification: Class I Status: Terminated

Product Description

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

Reason for Recall

Cross Contamination with other products: trace amounts of lidocaine

Recalling Firm

Fresenius Kabi USA, LLC — Lake Zurich, IL

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

13,525 bottles

Distribution

USA Nationwide

Code Information

Lot #: 6123925

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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