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Public Alert No. 017/2021 – Alert on the Recall of Defective Chemotherapy Medication

June 4, 2021,

The National Agency for Food and Drug Administration and Control has been informed that Chilean National Drug Agency (ANAMED) has recalled a chemotherapy medication, Brexil injectable solution (20mg/0.5ml), manufactured by an Italian Pharmaceutical Company, Actavis Italy Spa. This recall was due to the impaired functionality of Methotrexate which is the active ingredient.

Methotrexate is used to treat certain types of cancer or to control severe psoriasis or rheumatoid arthritis. It may also be used to control juvenile rheumatoid arthritis.

The details of the product are as shown below;

Product Name Brexil Injectable Solution (20mg/0.5ml)
Product Manufacturer Actavis Italy Spa
Lot Number 9GC5023
Expiry date April, 2021
Active ingredient Methotrexate

NAFDAC implores importers, distributors, healthcare professionals and patients to exercise caution and vigilance to avoid the importation, distribution, sale and use of the affected lot of Brexil Injectable Solution (20mg/0.5ml).

Members of the public in possession of the implicated product are implored to discontinue sale or use and submit stock to the nearest NAFDAC office.

Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of this drug to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks), via pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng  

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

Signed Management

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