Tag: product recall

Categories : Healthcare Politics and RegulationsTags :

SAHPRA Releases Results Of Investigation Following Recall Of Benylin Paediatric Syrup

On By ModernMedia
Photo by cottonbro studio

On 13 April 2024, the South African Health Products Regulatory Authority (SAHPRA) initiated a precautionary recall of two batches of Benylin Paediatric Syrup (batch numbers 329303 and 329304), in response to reported high levels of diethylene glycol in an alert by the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC). The recall was implemented as a precaution to protect lives while SAHPRA investigated the reported high levels of diethylene glycol.

As the national regulatory authority for health products in South Africa, SAHPRA implements health product recalls as a crucial measure to address safety concerns or quality issues in the interest of public health.

As part of the investigation of the reported high levels of diethylene glycol, SAHPRA tested samples of the two affected batches of Benylin Paediatric syrup through an independent laboratory and a method developed by the World Health Organisation for testing products for the presence of diethylene glycol. The tests did not find traces of diethylene glycol in the recalled batches. This indicates that units of batches 329303 and 329304 that were stored at the required temperature would not contain unacceptable levels of diethylene glycol.

SAHPRA also wishes to indicate that there is no record of any adverse drug reactions relating to diethylene glycol for the two recalled batches in South Africa or anywhere else where they were exported to on the continent.

SAHPRA is mandated to regulate and apply due diligence to health products to ensure that products in circulation in South Africa and those exported from SAHPRA-licensed manufacturers are safe for public consumption. SAHPRA applies this due diligence throughout the product life cycle, from registration through to post-market monitoring.

“SAHPRA will continue to closely monitor medical products that have the potential of containing unacceptable levels of diethylene glycol. And we will continue to address safety concerns or quality issues so that the health of the public is protected,” says SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.

Source: SAHPRA

Categories : Healthcare Politics and RegulationsTags :

SAHPRA Recalls Two Batches Of Benylin Paediatric Syrup

On By ModernMedia
Photo by cottonbro studio

On 10 April 2024, the South African Health Products Regulatory Authority (SAHPRA) received a report from the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) regarding the detection of high levels of diethylene glycol in a batch of Benylin Paediatric Syrup. SAHPRA immediately contacted the South African manufacturer, Kenvue (formerly Johnson and Johnson) for a response. Following engagements with the manufacturer and in the best interest of the public, it was resolved that affected batches would immediately be recalled while an investigation is ongoing.

SAHPRA, in collaboration with Kenvue, have identified the affected batch numbers as 329304 and 329303. These affected batches have been distributed to the following countries: South Africa, Eswatini, Rwanda, Kenya, Tanzania and Nigeria.

Benylin Paediatric presents as a clear, bright red syrup having a raspberry odour and taste, packed in amber glass bottles containing 100 mL with a plastic measuring cup. It is indicated for the relief of cough and its congestive symptoms and for the treatment of hay fever and other allergic conditions affecting the upper respiratory tract.

SAHPRA wishes to inform the public not to panic as the matter is being handled with priority. Batch recalls are batch-specific and do not necessarily apply to other batches/similar products. The manufacturer is a SAHPRA-licenced manufacturer and complies with Good Manufacturing Practices. The public is reminded that the recall is limited to two batches and should not panic regarding the range of products bearing the same name.

SAHPRA is alerting healthcare professionals and the public to discontinue the use of the two batches mentioned, remove them from their inventory and return them to their normal distribution channel(s) with immediate effect.

Classification of the recalls

The recall is classified as a Class 1, Type A recall, which is associated with a serious product quality concern that may have severe consequences. This is a country-wide recall. The product is being recalled from hospitals, retail outlets, healthcare professionals, authorised prescribers and individual customers or patients.

What the public should know

Diethylene glycol is toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headaches, altered mental state, and acute kidney injury which may lead to death.

Members of the public who have consumed these two batches who experience any adverse reaction or witness it in children should consult their healthcare professional and report this using the Med Safety App or send an email to: adr@sahpra.org.za.

The recall is limited to batch numbers 329304 and 329303 of Benylin Paediatric Syrup.

“As a national regulatory authority, the recalling of medical products is a crucial measure to address safety concerns or quality issues so that we protect the health of the public. SAHPRA is recalling these two batches from the market due to reported high levels of diethylene glycol, with the potential to cause serious adverse events,” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.

Source: SAHPRA

Categories : Healthcare Politics and Regulations Medical IndustryTags :

SAHPRA Recalls Lubri-A, Sterile Lubricating Gel

On By ModernMedia
Photo by Jan Kopřiva on Unsplash

The South African Health Products Regulatory Authority (SAHPRA) is aware of the product Lubri-A (Sterile Lubricating Jelly) manufactured by Electro-Spyres, classified as Class B medical device and currently being distributed across the country. 

SAHPRA has been informed of multiple complaints received from health institutions, both public and private across the country. The complaints are as a result of a number of patients who became ill due to developing a fungal infection, caused by exposure to the fungal species, Wickerhamomyces anomalus (previously Candida pelliculosa) associated with use of Lubri-A (Sterile Lubricating Jelly).

Lubri-A is available in two presentations, the 2.5 g sachets and 50 g tubes.

Considering the wide usage of the product for lubricating purposes in medical and surgical procedures, the Regulator has taken a decision to urgently recall this product from the market as there are multiple contaminated batches, with the potential to cause serious and widespread nosocomial infections. SAHPRA is alerting healthcare professionals and the public to discontinue the use of the product, remove it from their inventory and return it through their normal distribution channel(s) with immediate effect.

As the source of the contamination of the product is still under investigation and not confirmed, all batches of Lubri-A are being recalled. Future manufacture and distribution of the product will be subject to review and authorisation by SAHPRA.

Classification of the recalls

The recall is being classified as a Class 1, Type A recall, which is associated with a serious product quality concern that may have severe consequences. This is a countrywide recall. The product is being recalled from hospitals, retail outlets, health care professionals, authorised prescribers and individual customers or patients.

What the public should know

Healthcare professionals that have used this product should contact their patients to determine any symptoms of infection after use of product.

The recall is limited to the product called LUBRI-A (2.5g and 50g sachets) and does not affect other lubricating gel products authorised for sale in South Africa.

The contact telephone numbers for Electro-Spyres are:

Landline:         011-608-3998 or 011-402-7208

WhatApp:       +27-82-355-8862

“As a national regulatory authority, the recalling of medical products is a crucial measure to address safety concerns or quality issues so that we protect the health of the public. SAHPRA is recalling this product from the market as there are multiple suspected contaminated batches with the potential to cause serious and widespread nosocomial infections, ” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.