Class II · Moderate risk
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
CGMP Deviations
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Cross Contamination with other products: trace amounts of lidocaine
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
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
Affected NDC
63323-0671-05
Compare with the code on your package — it is the most precise check available.
Drug: Dexmedetomidine
- Recalling firm
- Fresenius Kabi USA, LLC
- NDC code
- 63323-671-05
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0120-2021 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Dexmedetomidine recalls
See all
Class II · Moderate risk
dexmedeTOMIDine HCl PF
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL
cGMP deviations: Temperature abuse
Class I · High risk
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
Cross Contamination with other products: trace amounts of lidocaine
Class II · Moderate risk
Dexmedetomidine 400 mcg in NS 100 mL bag
Lack of sterility assurance.
Other recalls by Fresenius Kabi USA, LLC
All 2020 recalls
Class I · High risk
Tyenne (tocilizumab-aazg)
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Class I · High risk
Morphine Sulfate Injection
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
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