The National Agency for Food and Drug Administration and Control has been informed that China Food and Drug Administration (CFDA) has ordered Changchun Changsheng Life Sciences Limited to stop production of Rabies Vaccines for human use.
The CFDA launches investigation into the company over illegal production of the vaccines. It was established that the company fabricated production and inspection records; arbitrarily changed process parameters and equipment during its production of freeze dried human Rabies Vaccines.
The company`s Good Manufacturing Practices (GMP) Certificate has been revoked by CFDA following violations of relevant law and regulations. The CFDA has ordered the recall of Rabies Vaccine Freeze Dried (Vero Cell).
Details of the affected Vaccines are:
Production Name: Rabies Vaccines for Human use (Vero cell) freeze dried.
Manufacturer: Changchun Changsheng Life Sciences Limited, 1615 Yeuda Road, Changchun, China.
MAH: Manfess Pharm. Nigeria Ltd, 3 Balewa Street Fegge, Onitsha, Anambra State
NRN: A6-0188
Product Name: Cross and Crown Rabies Vaccines,
Manufacturer: Changchun Changsheng Life Sciences Limited, 1615 Yeuda Road, Changchun, China.
MAH: Omed Pharmacy, 47 Modebe Avenue, Onitsha, Anambra State.
NRN: A6-0433
NAFDAC implores all importers to ensure that they do not import vaccines manufactured by Changchun Changshen Changsheng Life Sciences Limited, 1615, Yeuda Road, Changchun, China into Nigeria.
Healthcare providers in possession of the affected Vaccines should stop their use and submit them to the nearest NAFDAC office.
Consumers and Heath care providers are advised to report adverse event following immunization (AEFI) to nearest NAFDAC office,NAFDAC PRASCOR (20543 TOLLFREE from all network)or pharmacovigilance@nafdac.gov.ng
NAFDAC………..Safeguarding the health of the nation!!!
