Why it was recalled
Cross Contamination with other products: trace amounts of lidocaine
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 6121853, Exp 05/2021; 6122207, Exp 06/2021
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1537-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 22, 2020
- FDA report date
- Sep 2, 2020
- Quantity
- 25,100 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-1537-2020, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 86095
- Address
- 3 Corporate Dr
- Code information
- Lot #: 6121853, Exp 05/2021; 6122207, Exp 06/2021
- Postal code
- 60047-8930
- Report date
- Sep 2, 2020
- Product type
- Drugs
- Recall number
- D-1537-2020
- Classification
- Class I
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 25,100 bottles
- Termination date
- Sep 12, 2022
- Reason for recall
- Cross Contamination with other products: trace amounts of lidocaine
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Jul 22, 2020
- Initial firm notification
- Press Release
- Center classification date
- Aug 21, 2020