Friday, August 8, 2025 - NAFDAC is alerting the public to the recall of Amoxivue (Amoxicillin) 500mg, with NAFDAC No. A4-100178 and Batch No. 322584, manufactured by Sparsh Bio-Tech Pvt, Ltd.
In a statement released today August 7, the agency said a
batch of Amoxivue (Amoxicillin) 500mg capsules, manufactured in 10/2023 and
expiring in 10/2026, was sampled from a facility in Sokoto and two facilities
in 2 Local Government Areas in Plateau State.
The agecy said the capsules were analysed using
High-Performance Liquid Chromatography (HPLC) and Fourier Transform Infrared
Spectroscopy (FTIR). The laboratory analysis report showed that the API content
was significantly low at 26.3%.
‘’The weight
variation and infrared absorption spectrum of the sample residue did not meet
the established specifications. This indicates that the product is substandard,
which has led to its recall.
Amoxivue
(Amoxicillin) 500 mg capsules is an antibiotic used to treat various bacterial
infections, including respiratory tract infections, ear infections, sinus
infections, urinary tract infections, and skin and soft tissue infections. It
contains amoxicillin, a penicillin-type antibiotic that works by inhibiting the
growth of bacteria.
Risk
Statement
Administration
of Amoxivue (Amoxicillin) 500 mg with low levels of amoxicillin may lead to
therapeutic failure, antibiotic resistance, increased risk of complications,
misleading clinical assessments, and poses a risk to public health.''the
statement reads in part
The agency said healthcare professionals and consumers are
advised to report any suspicion of the sale of substandard and falsified
medicines or medical devices to the nearest NAFDAC office, call 0800-162-3322 or
send an email to sf.alert@nafdac.gov.ng
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