Two Boxes of Benylin Pediatric Cough Syrup Are Recalled by SAHPRA.

Two lots of Benylin pediatric cough syrup have been recalled by the South African Health Products Regulatory Authority (SAHPRA).

The Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) notified the relevant party on April 10, 2024, that significant quantities of diethylene glycol had been found in a batch of Benylin pediatric cough syrup.

Diethylene glycol can be lethal to humans if consumed, according to the SAHPRA.

Abdominal discomfort, vomiting, diarrhea, difficulty urinating, headaches, altered mental state, and severe renal injury that may be fatal are examples of toxic consequences.

“For a response, SAHPRA got in touch with the manufacturer, Kenvue, which was formerly Johnson & Johnson, in South Africa right away. The implicated batches will be promptly recalled while an investigation is ongoing, the local drug watchdog stated, after discussions with the producer and in the public interest.

In cooperation with Kenvue, SAHPRA has determined that batch numbers 329304 and 329303 are impacted.

Several nations, including South Africa, Eswatini, Rwanda, Kenya, Tanzania, and Nigeria, have received these impacted batches.

According to Dr. Boitumelo Semete-Makokotlela, CEO of SAHPRA, recalling medical products is an essential step in addressing safety or quality issues, protecting public health. SAHPRA is a national regulatory authority.

Due to observed excessive amounts of diethylene glycol, which have the potential to cause major adverse reactions, SAHPRA is recalling these two batches from distribution, according to Semete-Makokotlela.

Benylin Pediatric comes in a 100ml amber glass bottle with a plastic measuring cup. It is a brilliant red syrup with a raspberry flavor and aroma.

It is used to treat upper respiratory tract allergens such as hay fever and others, as well as cough and congestive symptoms.

“SAHPRA wants the public to know that the issue is being handled with urgency and they shouldn’t panic. Recalls for certain batches are batch-specific and may not apply to other batches or comparable products. According to Semete-Makokotlela, “The manufacturer complies with Good Manufacturing Practices (GMP) and holds a SAHPRA license.

The public shouldn’t panic over the variety of items with the same name, the pharma watchdog emphasized, as the recall is only affecting two batches.

Semete-Makokotlela stated, “SAHPRA is warning healthcare providers and the public to stop using the two batches mentioned, remove them from their inventory, and return them to their regular distribution channels immediately.”

Class 1, Type A recalls are those that are linked to major product quality issues that could have dire repercussions. This recall falls under this category.

This is a nationwide recall, according to SAHPRA, affecting hospitals, retail establishments, medical professionals, licensed prescribers, and individual consumers or patients.