The National Agency for Food and Drugs Administration and Control (NAFDAC) has recalled Benylin paediatric syrup manufactured by Johnson & Johnson over safety concerns.
Benylin paediatric syrup is used for the relief of cough, and congestive symptoms.
The syrup is also applied in the treatment of hay fever and other allergic conditions in children aged two to 12 years.
A product recall is a request to return to the maker, a
batch, or an entire production run of a product, usually over safety concerns,
design defects, or labelling errors.
In a statement on Wednesday, NAFDAC said laboratory analysis
conducted on the syrup showed that it contains an unacceptable high level of
diethylene glycol which is toxic to humans when consumed and can prove fatal.
The agency said the medicine was also found to cause acute
oral toxicity in laboratory animals.
“Toxic effects to humans can include abdominal pain,
vomiting, diarrhoea, inability to pass urine, headache, altered mental state,
and acute kidney injury which may lead to death,“ the statement reads.
”NAFDAC implores importers, distributors, retailers and
consumers to exercise caution and vigilance within the supply chain to avoid
the importation, distribution, sale and use of the substandard (contaminated)
regulated products. All medical products must be obtained from
authorized/licensed suppliers.
”The products’ authenticity and physical condition should be
carefully checked. Anyone in possession of the above-mentioned product is
advised to immediately discontinue the sale or use and submit stock to the
nearest NAFDAC office.
“If you witness any adverse reaction/event after the use of
this product in any children, you are advised to direct such patients for
immediate medical attention from a qualified healthcare professional.
“Healthcare professionals and consumers are advised to
report any suspicion of substandard and falsified medicines to the nearest
NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng.
“Similarly,
healthcare professionals and patients are also encouraged to report adverse
events or side effects related to the use of the 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 or via the Med-safety
application available for download on android and IOS stores or via e-mail on
pharmacovigilance@nafdac.gov.ng.
“The Agency has directed the Marketing Authorization Holder
(Johnson and Johnson company West Africa) to initiate the recall of the batch
and the notice will also be uploaded to the WHO Global Surveillance and
Monitoring System (GSMS).”
Advertise on NigerianEye.com to reach thousands of our daily users
No comments
Post a Comment
Kindly drop a comment below.
(Comments are moderated. Clean comments will be approved immediately)
Advert Enquires - Reach out to us at NigerianEye@gmail.com