Dexmedetomidine HCl in 0.9% Sodium Chloride Injection recall: Contamination
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…
Why was Dexmedetomidine HCl in 0.9% Sodium Chloride Injection recalled?
Cross Contamination with other products: trace amounts of lidocaine
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 6123925
- 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…
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 13,525 bottles
- Distribution
- USA Nationwide
- Recall date
- December 16, 2020
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)