Public Alert No: 0025/2018 – Potential Risk Of Glass Particles In Firmagon 1500 IU & 5000 IU Powder For Injection
National Agency for Food and Drug Administration and Control (NAFDAC) has been notified by European Medicines Agency of potential risk of glass particles in vials of Lyophilized Firmagon (Highly Purified Human Chorionic Gonadotrophin) powder for injection manufactured by Ferring GmbH, Wittland 11 24109 Kiel, Germany.
The glass particles in the product are due to glass breakage at the vial inlet during filling operations.
The European Medicines Agency requested for the deviation and investigation reports from the manufacturer following two quality complaints regarding glass particles in vials of Firmagon Powder for injection. The report revealed severe technical problems at the concerned filling line as well as an imprecise procedure for the intervention during the aseptic process.
Ferring Highly Purified Human Chorionic Gonadotrophin (HP-hCG) is urine derived hCG available in vials in two strengths (1500 IU and 5000 IU). It is presented as lyophilized powder with a solvent for solution for injection.
Ferring HP-hCG is marketed in various countries under different brand names. The brand names include Firmagon, Chorapur, Choragon, Gonax and Brevactid.
The batch numbers, strength, manufacturing and expiry date of HP-hCG identified to have had glass breakage at the inlet of the filling machine are shown below:
|Product||Strength (IU)||Batch||Manufacturing date||Expiry date||Countries where distributed|
|HP-hCG||1500||M11450||11-Apr-2016||Apr / 2019||Germany, Russian Federation|
|HP-hCG||5000||M11453||15-Apr-2016||Apr / 2019||Germany, Slovenia, Mauritius, Denmark, Hong Kong, Saudi Arabia|
|HP-hCG||1500||M14238||25-Jul-2016||Jul / 2017||Russian Federation|
|HP-hCG||1500||N11461||13-Mar-2017||Mar / 2020||Germany, Kazakhstan|
|HP-hCG||1500||N12932||09-Jun-2017||Jun / 2020||Germany, Slovenia|
|HP-hCG||5000 MX||N15061||25-Sep-2017||Sep / 2020||Mexico|
|HP-hCG||1500||P11497||20-Apr-2018||Apr / 2021||Finished product not yet distributed to any market.|
The indications for Ferring HP-hCG include establishment of fertility in cases of hypogonadotrophic hypogonadism, treatment of undescended testes, triggering of ovulation and Luteinisation induction after stimulation of follicle growth; and assisted reproductive technology program such as in vitro fertilization.
Ferring HP-hCG products are for dedicated treatment and are not held on big stock in Pharmacies or wholesale outlets.
Patients that are administered the defective product may have the glass particles embedded at the injection site and are likely to report sensation of foreign bodies, injection site pain and foreign body granulomas.
NAFDAC implores Healthcare Providers, especially those working in Fertility Clinics to be vigilant to detect and report adverse reactions associated with the use of Firmagon to the National Pharmacovigilance Center, Abuja or to the nearest NAFDAC Office.
NAFDAC………..Safeguarding the health of the nation!!!