Recalls / Class I
Class ID-0120-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Dexmedetomidine Hydrochloride
- Generic name
- Dexmedetomidine Hydrochloride
- Active ingredient
- Dexmedetomidine Hydrochloride
- Route
- Intravenous
- NDC
- 63323-671
- FDA application
- ANDA208129
- Affected lot / code info
- Lot #: 6123925
Why it was recalled
Cross Contamination with other products: trace amounts of lidocaine
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 13,525 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2020-11-17
- FDA classified
- 2020-12-08
- Posted by FDA
- 2020-12-16
- Terminated
- 2022-09-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0120-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.