The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted healthcare providers, importers, distributors and caregivers to the recall of approximately 90,000 bottles of Children’s Ibuprofen Oral Suspension in the US due to contamination concerns.
In a public alert issued on Saturday, the agency said it received notification that the United States Food and Drug Administration had announced the recall following reports of foreign material in the product.
According to NAFDAC, the recall was initiated by Strides Pharma Inc. after consumers complained of a “gel-like mass” and “black particles” in the oral suspension.
Children’s Ibuprofen Oral Suspension, USP (100 mg/5 mL), is commonly used to relieve pain associated with the common cold, flu, sore throat, headache and toothache in children, and to reduce fever.
Health risks
NAFDAC warned that the presence of foreign material in medicinal products could compromise their quality, safety and effectiveness.
The agency noted that administering contaminated oral suspensions may result in adverse reactions, particularly among children, and could pose choking or gastrointestinal risks depending on the nature of the contaminant.
Affected products
The affected product is Children’s Ibuprofen Oral Suspension, USP, 100 mg/5 mL, packaged in 120 mL (4 fl. oz.) bottles.
The product was manufactured by Strides Pharma Inc. in India for Taro Pharmaceuticals U.S.A., Inc.
NAFDAC said the affected batches are lot numbers 7261973A and 7261974A, with an expiry date of 31 January 2027.
The recalled products were distributed nationwide in the US.
Surveillance in Nigeria
Although the affected products were distributed and recalled within the US, NAFDAC said it is taking precautionary measures to prevent them from entering Nigeria through authorised or unauthorised channels.
The agency said it had directed all its zonal directors and state coordinators to intensify surveillance activities and remove the products from circulation if found in their jurisdictions.
“NAFDAC remains committed to safeguarding public health and will continue surveillance activities to ensure the quality, safety and efficacy of medicines circulating in Nigeria,” the agency said.
Advice to healthcare providers, parents
NAFDAC advised importers, distributors, retailers and healthcare professionals to remain vigilant and ensure that medical products are sourced only from authorised and licensed suppliers.
The agency also urged healthcare facilities to immediately inspect their inventories and quarantine any affected batches if identified.
Parents and caregivers who possess the recalled products, or who may have administered them to children, were advised to stop using them immediately and seek medical attention if any unusual reactions are observed.
NAFDAC further encouraged healthcare professionals and members of the public to report adverse reactions associated with medicinal products through its pharmacovigilance channels, including its e-reporting platform and the Med Safety mobile application.
The agency said reports could also be submitted through the nearest NAFDAC office or via its designated pharmacovigilance email address.
The World Health Organisation (WHO) has recommended a Phase III trial of an Ebola vaccine to test whether it can protect against Bundibugyo virus disease.
WHO Director-General, Tedros Ghebreyesus, disclosed this in a video posted on his official X account on Thursday.
Ghebreyesus said two vaccines specifically developed against the Bundibugyo virus had entered Phase I safety trials in humans. At the same time, new animal studies had shown promising evidence that Ervebo, an Ebola vaccine, could also provide cross-protection against the virus.
He said the findings prompted WHO to recommend Ervebo for inclusion in a Phase III trial, which the organisation hopes to begin as soon as possible.
However, it is not yet known whether Ervebo can protect humans against Bundibugyo virus disease.
Mr Ghebreyesus said the Phase III trial would help establish whether the vaccine is safe and effective and could provide evidence needed to make it available for the current outbreak and future outbreaks.
No licensed vaccines
The development comes as the Bundibugyo virus outbreak in the DRC has become the second-largest Ebola outbreak on record.
As of Thursday, the country had recorded 4,449 confirmed cases and 2,061 deaths across five provinces and 53 health zones, according to the WHO.
The health agency said the outbreak was spreading faster than any previous Ebola outbreak at the same stage and could surpass the 2014–2016 West African outbreak, which remains the largest on record, with more than 28,000 cases and 11,000 deaths reported in Guinea, Liberia and Sierra Leone.
Bundibugyo virus is one of the viruses in the Ebola family that can cause severe and often fatal disease in humans.
Unlike Ebola virus disease caused by the Ebola virus, there is currently no licensed vaccine specifically approved for the prevention of Bundibugyo virus disease.
WHO said in June that Ervebo, the only licensed and WHO-prequalified Ebola vaccine, is approved for Ebola virus disease but not for Bundibugyo virus disease.
The current outbreak was first detected in the DRC in May, following an unexplained cluster of deaths in Ituri Province that was investigated. Laboratory testing confirmed Bundibugyo virus disease, prompting the DRC government to declare its 17th Ebola outbreak.
Uganda also confirmed imported cases linked to the outbreak in the DRC. WHO subsequently determined that the outbreak in the two countries constituted a Public Health Emergency of International Concern.
Previous Bundibugyo virus outbreaks have had case fatality rates between 30 and 50 per cent, according to the WHO.
PREMIUM TIMES reported on 9 August that WHO had already recommended Ervebo for evaluation in a randomised clinical trial after reviewing evidence suggesting that it could provide some protection against Bundibugyo virus.
Treatment advancement
Mr Ghebreyesus also disclosed progress in research into treatments for Bundibugyo virus disease.
He said a WHO-sponsored partners trial had reached 100 patients.
The trial is assessing potential treatments for the disease and is intended to generate evidence on which therapies can improve outcomes for infected patients.
Mr Ghebreyesus said the milestone showed that research could be mobilised rapidly and responsibly even during a difficult outbreak.
He called on partners to support and accelerate the vaccine trial, while emphasising that the response requires collaboration among the DRC government, WHO, Africa Centres for Disease Control and Prevention (CDC) and other partners.
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For many women in Kano, the risks associated with childbirth begin long before labour.
Cultural beliefs, religious misconceptions, financial hardship, delayed antenatal care and reliance on traditional remedies can prevent pregnant women from reaching health facilities when they need care.
These barriers were highlighted at a two-day interfaith workshop in Kano, where religious leaders, health professionals, government officials and development partners examined how communities can help reduce maternal deaths.
The workshop, titled “Save Lives: An Interfaith Workshop on Reducing Maternal Mortality”, was organised under the Advocacy and Implementation of Maternal, Newborn, Child Nutrition and Health (AIM-MNCNH) project and held on Monday in Kano State.
Participants examined the “three delays” associated with maternal deaths and findings from community dialogues in Gaya Local Government Area of Kano State.
Participants discussing at the two-day interfaith workshop held at Tahir Guest Palace, Kano State.
The discussions showed that access to care is often determined by more than the availability of health facilities. Decisions by husbands and older family members, transport difficulties and beliefs about childbirth can all determine whether a woman receives timely care.
‘People listen to religious leaders’
Speaking on the role of religious leaders, Adeniyi Ogunbanwo, Secretary of the Christian Association of Nigeria (CAN) in Kano State, said they could play a significant role because of the trust communities place in them.
Mr Ogunbanwo said churches could use sermons, weddings, naming ceremonies and other gatherings to educate families about maternal health.
“Religious leaders, in terms of being realistic, people listen to us. So, we have a lot to play, and mostly by speaking,” he said.
Participants discussing at the two-day interfaith workshop held at Tahir Guest Palace, Kano State.
He said churches could also support women who struggle to pay medical bills, noting that some churches have maternity wards.
However, Mr Ogunbanwo warned that religious beliefs should not be used to discourage women from seeking professional medical care.
He said some women interpret biblical references to childbirth as meaning they should be able to deliver without medical assistance.
According to him, CAN had been engaging the Kano State Primary Healthcare Board and other government structures on maternal health and would develop a sermon guide for churches across the state.
Participants discussing at the two-day interfaith workshop held at Tahir Guest Palace, Kano State.
Family decisions
Beyond religious teachings, the discussions also highlighted the influence of family members on women’s decisions about seeking care.
Speaking on the findings from community engagements, Maryam Danjuma, Community Engagement Officer with Pathfinder International, said many pregnant women were not the final decision-makers when it came to seeking antenatal or delivery care.
Ms Danjuma said women often depended on their husbands, while husbands could themselves be influenced by mothers-in-law and older women in their communities.
Dr Olufemi Ibitoye
She said some older women who had delivered at home in the past sometimes considered women who preferred health facilities to be lazy.
Ms Danjuma recalled a case discussed during a town-hall meeting in which a woman died after her relatives opposed her husband’s decision to take her to a health facility.
She also recalled a contrasting case in which a husband insisted that his wife register for antenatal care despite her initial refusal.
Transport and harmful practices worsen delays
Speaking further on the barriers identified during the community dialogue, Ms Danjuma said distance and transportation costs compounded the problem, particularly for women living in remote communities.
She said some communities were far from health facilities and lacked affordable transport.
She also raised concerns about “ruwan naƙuda”, a substance some women take during labour, sometimes mixed with herbs or pills.
Maryam Haruna Danjuma
According to her, the practice is deeply rooted in some communities and can cause complications.
Ms Danjuma said the challenges require community actors to work together rather than treating religious leaders as the only solution.
She said Pathfinder was therefore engaging men, health workers, traditional birth attendants and other influential community members.
Speaking on the role of traditional birth attendants, she said they could be part of the solution by referring women to health facilities, particularly when complications arise.
She added that some community meetings were also held inside health facilities to familiarise women with the environment and address concerns about privacy and treatment.
JNI challenges misconceptions about hospital care
The need to address misconceptions about medical care was also emphasised by Muhammad Gwagwarwa, Chairman of Jama’atu Nasril Islam (JNI) in Kano State.
Mr Gwagwarwa said religious leaders had a responsibility to challenge beliefs that discourage women from seeking medical care.
Habiba Abubakar Mijin-Yawa, Ameera of the Federation of Muslim Women of Nigeria, Kano State chapter
He said the organisation was invited to bring Islamic scholars together to discuss ways of reducing maternal deaths during and after childbirth.
Speaking on the scale of the problem, Mr Gwagwarwa said the figure presented at the workshop showed Nigeria accounts for 27 per cent of global maternal deaths.
He said some families believe seeking hospital care is unnecessary because childbirth is ultimately determined by God.
However, he stressed that Islam encourages people to seek treatment from medical professionals.
“Islam has established that people should seek healthcare and go to those who are experts in the field of health.
“Therefore, staying at home, refusing to go to the hospital and relying on fate has also contributed to these deaths,” he added.
Mr Gwagwarwa also attributed some of the challenges to the decline in experienced traditional birth attendants, saying those who previously assisted women had acquired considerable knowledge through years of practice.
He said JNI would take maternal health messages beyond mosques to schools, marriage ceremonies, Qur’anic learning centres, Maulud gatherings and Islamiyyah schools.
Muhammad Nuraddeen Gwagwarwa, chairman of Jama’atu Nasril Islam (JNI) in Kano State
Responsibility extends beyond families
While the discussions focused strongly on beliefs and family decisions, Habiba Mijin-Yawa, Ameera of the Federation of Muslim Women of Nigeria, Kano State chapter, said responsibility for reducing maternal deaths extends beyond families.
Ms Mijin-Yawa said families, communities, government and health facilities all had roles to play.
She identified beliefs, irresponsible husbands and women’s attitudes among the challenges.
However, she, said the government and health facilities must also address gaps that discourage women from seeking care.
“This is not only on the husband, but also the government and even the hospitals,” she said.
Pathfinder seeks measurable change
Speaking on the expected outcome of the workshop, Olufemi Ibitoye, Technical Adviser, MNCH at Pathfinder International, said the initiative was designed to move religious leaders beyond advocacy towards measurable action.
Mr Ibitoye said Kano was selected because of its high burden of maternal mortality, with religious leaders drawn from high-burden local government areas.
He said participants had developed action plans for taking maternal health messages into their communities.
“What we are doing here is actually to save lives, an interfaith workshop to reduce maternal mortality in Kano State,” he said.
The project is funded by the Gates Foundation through a consortium led by ACEPHAP, with Pathfinder International, CCSI and American Women’s Association of Nigeria as supporting partners.
Mr Ibitoye said a sermon guide had also been developed to help religious leaders address antenatal care, danger signs and skilled birth attendance.
According to him, the initiative will use existing structures to track whether the intervention is producing results.
He said health promotion and advocacy officers at the LGA level would work with religious and community leaders to monitor antenatal attendance, facility deliveries, complications and maternal deaths.
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