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.

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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.

Menopause, the natural stage marking the end of a woman’s reproductive years, can significantly affect bone health and increase the risk of osteoporosis and fractures due to declining oestrogen levels, a medical expert has said.

Although menopause has important health implications, it remains a frequently overlooked issue within Nigeria’s sexual and reproductive health and rights framework.

According to the World Health Organisation (WHO), menopause occurs when a woman’s menstrual periods stop permanently because of declining levels of oestrogen and the loss of ovarian follicular function. As a result, the ovaries stop releasing eggs for fertilisation, making natural conception no longer possible.

Common symptoms associated with menopause include hot flushes, night sweats, irregular menstrual flow, vaginal dryness, pain during sexual intercourse, urinary incontinence, sleep disturbances, mood changes, anxiety and depression.

Perimenopause refers to the transition period leading to menopause and extends until one year after the final menstrual period, while postmenopause begins after a woman has gone 12 consecutive months without menstruation.

In Nigeria, women generally attain menopause around the age of 48 and above as part of the natural ageing process.

Menopause and bone health

Speaking with PT Health Watch, Qudus Lawal, an obstetrician and gynaecologist, said menopause disrupts hormonal balance, leading to increased bone breakdown and reduced bone formation.

According to him, while nearly all women experience some degree of bone loss after menopause because of declining oestrogen levels, not all will develop osteoporosis or sustain fractures.

He explained that bone density before menopause plays a major role in determining a woman’s risk of osteoporosis later in life.

Using a financial analogy, Mr Lawal described bone health as a balance between deposits and withdrawals.

“The stronger the bone density a woman builds before menopause, the better protected she is against the accelerated loss that occurs afterwards,” he said.

Why bone loss increases after menopause

Mr Lawal explained that oestrogen normally suppresses osteoclasts, the cells responsible for breaking down bone tissue.

However, when oestrogen levels fall after menopause, these cells become more active, while osteoblasts, the cells responsible for building new bone, are unable to replace bone at the same rate.

This imbalance gradually weakens bones and increases the risk of osteoporosis and fractures.

Maintaining healthy bones after menopause

Mr Lawal recommended a combination of proper nutrition, regular exercise and preventive healthcare measures to maintain bone health after menopause.

He advised women to consume balanced diets rich in calcium and vitamin D, engage in weight-bearing and muscle-strengthening exercises, and take steps to prevent falls.

“When you take foods and supplements that are rich in those essential nutrients, it helps build the bone,” he said.

He stressed the importance of early intervention, noting that bone density loss is often silent and may not produce symptoms until complications occur.

“One of the ways people present is that they grow shorter. Normally, once you get to a certain age after puberty, you are not supposed to grow shorter.

“But many of our mothers begin to lose height over time, which may result from age-related spinal degeneration and bone loss,” he said.

According to him, many women only become aware of significant bone loss after suffering fractures.

“The fracture can be due to a fall, sometimes a little push that you normally have without having symptoms. Just a little trip in the bathroom could lead to a major fracture,” he added.

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Mr Lawal noted that in some countries, bone density screening forms part of routine wellness checks for postmenopausal women, helping identify individuals at high risk and allowing for early intervention.

He urged women to adopt healthy lifestyles and prioritise bone health long before menopause.

According to him, the goal is to ensure women build and maintain strong bone density before menopause to minimise the impact of hormonal changes later in life.