17th October, 2018
The National Agency for Food and Drug Administration and Control (NAFDAC) has banned the importation, sale and distribution of Malco Vitamin B Complex injection in Nigeria due to contamination.
The drug is produced by Shreechem Pharmaceuticals PVT Ltd, India.
The Director-General of the agency, Prof. Mojisola Adeyeye, announced the ban in a statement in Abuja on Wednesday.
Adeyeye said laboratory analysis by WHO indicates that the product is unfit for human consumption.
She said that use of the product could cause serious health hazard, urging healthcare providers and members of the public to stop the administration and use of the affected product to avoid negative health complications.
The director-general therefore directed all importers, wholesalers and retailers to immediately stop the importation, distribution and sale of Malco vitamin B complex injection.
She urged anyone in possession of the affected product to submit it to the nearest NAFDAC office.
Adeyeye also advised consumers to report any adverse events related to the use of the product to the nearest NAFDAC office or NAFDAC PRASCOR 20543 toll free.
“NAFDAC has been informed that the Zambia Medicines Regulatory Authority (ZARMA) has directed International Drug Company (IDC) Limited, Lusaka, Zambia, to recall all batches of Malco vitamin B complex injection manufactured by Shreechem Pharmaceuticals PVT Limited, India.
“The recall is a precautionary measure due to observed particulate materials possibly microbial growth in the bottles of the product.
“Preliminary observation from World Health Organisation (WHO) facilitated laboratory analysis indicates that the sample is unfit for human consumption.
“The body needs Vitamin B complex for various functions such as supporting cellular metabolism, maintaining healthy nerve cells and proper neurological function; aiding the bone marrow to produce healthy red blood cells and helps to control blood levels of homocysteine,’’ the statement read in part.
The director-general also noted that although Malco vitamin B complex injection was registered with NAFDAC, but its marketing authorisation license expired in 2016.