The National Agency for Food and Drug Administration and Control (NAFDAC) has received information from the US Food and Drug Administration, 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.
Administering Dexmedetomidine HCl containing lidocaine to a patient with lidocaine allergy could result in anaphylaxis, which could possibly threaten the life of the patient.
0.9% Sodium Chloride Injection combined with Dexmedetomidine Hydrochloride is approved for intravenous use and indicated for sedation of non-intubated patients.
The product name is Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, the size of the product is 200mcg/50mL (4mcg/mL). The NDC Number is 63323-671-50671050, the product Code is 6121853. The batch number is 6122207 and it’s expiration date is 06/2021.
NAFDAC has therefore advised healthcare professionals to desist from dispensing or distributing the above products with immediate effect and should not be sold at all.
NAFDAC thereby urged healthcare providers and patients 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 through mail- firstname.lastname@example.org.