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Voluntary Recall Of Two Lots Of Dexmedetomidine Hydrochloride Injection Due To Cross-Contamination Of Lidocaine

October 1, 2020,

The National Agency for Food and Drug Administration and Control (NAFDAC) has received information from the US FDA about the voluntary recall of two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200mcg/50mL (4mcg/mL), 50mL fill in a 50mL vial by Fresenius Kabi, USA

Fresenius Kabi initiated this recall due to the possibility that a trace amount of lidocaine is present in these two lots.

Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in anaphylaxis, a potentially life-threatening condition.

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Recalled Products details

Product Name/Product size NDC Number Product Code Batch Number Expiration Date
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200mcg/50mL (4mcg/mL), 50mL fill in a 50mL vial 63323-671-50 671050 6121853 05/2021
6122207 06/2021

Recommendations

Healthcare professionals are encouraged to:

  • Stop dispensing or distributing the above products immediately and remove from the shelves within your store.
  • Return unused products to the nearest NAFDAC office

Healthcare providers and Patients are advised to report adverse events and quality problems they experienced using these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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