The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by the US Food and Drug Administration about voluntary recall of one lot of Daptomycin for Injection, 500 mg/vial by Mylan Laboratories.
The retract is subject to the presence of particulate matter found in one single-dose vial.
NAFDAC stated that Daptomycin injection is an antibacterial specifically produced for the treatment of complicated skin and skin structure infections and staphylococcus aureus bloodstream infections (bacteremia) in adult patients.
NAFDAC further explained that it ude could lead to serious adverse effects such as allergic reactions, vasculitis/phlebitis, antigenic, microvascular among others.
The details of the affected lot of Daptomycin for Injection reveals that it’s strength is 500 mg/vial with a capacity of 20 mL/vial. It’s Lot No is 76051122 and will expire in October 2021 and manufactured by Mylan.
NAFDAC has in lieu of this ordered healthcare professionals and patients in possession of Daptomycin for Injection 500 mg/vial to stop it’s use and further distribution or dispensing and submit the product to the nearest NAFDAC office.
NAFDAC thereby urged Healthcare professionals to report any adverse events or side effects related to the use of the product to the nearest NAFDAC office, or through mail pharmacovigilance@nafdac.gov.ng.
Support InfoStride News' Credible Journalism: Only credible journalism can guarantee a fair, accountable and transparent society, including democracy and government. It involves a lot of efforts and money. We need your support. Click here to Donate