The National Agency for Food and Drug Administration and Control 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 (possible microbial growth) in bottles of the product.
Preliminary observation from World Health Organization (WHO) facilitated laboratory analysis indicates that the sample is unfit for human consumption. The use of this product may cause serious health hazards.
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 details of the recalled product are:
Product Name: MALCO Vitamin B-complex injection, 10ml
Product Manufacturer: Shreechem Pharmaceuticals PVT Limited, India.
Although, Malco Vitamin B complex Injection was registered with NAFDAC, its marketing authorization license expired in 2016.
NAFDAC implores all importers, wholesalers and retailers to immediately stop the importation, distribution and sale of Malco vitamin B complex injection.
Healthcare providers and members of the public are advised to stop the administration and use of the affected products to avoid negative health implications. Anybody in possession of the affected product should submit it to the nearest NAFDAC office.
Consumers are advised to report adverse events related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng
NAFDAC………..Safeguarding the health of the Nation!!!
