.jpeg)
The notification of this product is contained in a public
alert No. 036/2023, signed by the Director-General of the agency, Prof.
Mojisola Adeyeye, on Tuesday, in Abuja.
Adeyeye said that the agency was equally notified about the
injection by the Marketing Authorisation Holder Pfizer, who reported the
incident, as received through a patient notification platform.
The NAFDAC boss said Pfizer reported that the vial content
did not dissolve when reconstituted for use and that further visual inspection
of the pack was observed.
It was also reported that the crimp code did not match the
code reported on the production documentation batch of 2A21F11, which is the
semi-finished batch used for 4A21I17.
She said that the production process did not meet Pfizer’s
specifications.
“The vial label compares favourably to the purported artwork
version.
“Meronem (Meropenem trihydrate injection) is an antibiotic
used to treat skin and abdominal (stomach area) infections caused by bacteria
and meningitis (infection of the membranes that surround the brain and spinal
cord) in adults and children 3 months of age and older.
“The administration of the counterfeit product will pose a
high risk to patients as the quality and safety are not guaranteed,” Adeyeye
said.
The NAFDAC boss, however, said that healthcare providers and
patients were advised to obtain all medical products from authorised/licensed
suppliers.
She advised that the products’ authenticity and physical
condition should be carefully checked before purchase and administration.
She also implored importers, wholesalers and retailers to
maintain vigilance within the supply chain and desist from illegal importation,
distribution, and sale of the counterfeit Meronem 1g injection and other
substandard medicinal products.
She warned that anybody in possession of the counterfeit
product should stop using it, adding that it should be submitted to the nearest
NAFDAC office.
She also called on those with possession of the counterfeit
product to seek immediate medical advice from a qualified healthcare
professional if they already used the product, or suffered from any adverse
reaction after using the product.
Adeyey also advised healthcare professionals and consumers
to report any suspicion of adverse drug reactions, or substandard and falsified
medicines to the nearest NAFDAC office, or NAFDAC phone number at 0800-162-3322
or via email: sf.alert@nafdac.gov.ng.
Adeyeye also encouraged healthcare professionals and
patients to report adverse events or side effects related to the use of a
medicinal product to the nearest NAFDAC office, or through the use of the
E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng.
She also urged the public to report any adverse effect of
the product via the Med- safety application available for download on android
and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng.
NAN