BPOM Perintahkan Tarik Obat Sirup PT Samco Farma dan PT Ciubros Farma: Langgar Ketentuan

Summary

The video reports on a press conference held by the Indonesian National Agency of Drug and Food Control (BPOM) regarding the recall and destruction of syrup medications produced by PT Samco Farma and PT Chiupros Farma. Following the discovery of hazardous levels of ethylene glycol and diethylene glycol in their products, these companies were ordered to withdraw their syrup medications nationwide. The BPOM is actively monitoring this recall, which also involves the cessation of production and distribution of products using certain harmful solvents, reflecting ongoing concerns over acute kidney failure cases in children linked to contaminated medications.

Takeaways

• 🔍 The BPOM (Drug and Food Supervisory Agency) announced new findings during a press conference on November 9, 2022.
• 💊 Two pharmaceutical companies, PT Samco Farma and PT Chiupros Farma, were instructed to withdraw and destroy their syrup medicines across Indonesia.
• 🛑 Certain syrup products from PT Samco Farma (Samco Trial and Samconal) and PT Chiupros Farma (Cito Mall) were identified for recall due to contamination.
• ⚠️ Contaminants found included ethylene glycol (EG) and diethylene glycol (DEG), raising safety concerns for children's health.
• 👶 The presence of these harmful chemicals is suspected to be linked to acute kidney failure in children.
• 📉 All products containing EG and DEG above safe limits are subject to withdrawal from the market.
• 🔄 The responsibility for product withdrawal lies with the pharmaceutical companies, monitored actively by BPOM.
• 🏥 The withdrawal covers all pharmacies, government pharmaceutical installations, and private practices.
• 📝 Destruction of the syrup products will be supervised by BPOM technical staff, ensuring proper documentation.
• 📊 This action follows previous measures against three other pharmaceutical companies for similar violations, indicating ongoing regulatory scrutiny.

Q & A

What was the main issue addressed in the press conference held by BPOM?

The press conference addressed the recall and destruction of certain syrup medications produced by PT Samco Farma and PT Ciubros Farma due to contamination with harmful substances.

Which specific substances were found to contaminate the syrup medications?

Ethylen glycol (EG) and diethylen glycol (DEG) were the harmful substances found in the raw materials used for the syrup medications.

What health issue was linked to the contaminated syrup medications?

The contaminated syrup medications were suspected to cause acute kidney failure in children.

What actions did BPOM require from PT Samco Farma and PT Ciubros Farma?

BPOM required both companies to destroy and withdraw their syrup medications from circulation throughout Indonesia.

How will the withdrawal of the products be monitored?

The withdrawal will be accompanied and actively monitored by BPOM across all pharmacies, government health installations, and drug stores.

What products were specifically mentioned as being recalled?

The recalled products include 'Cito Mall' from PT Ciubros Farma and 'Samco Trial' and 'Samconal' from PT Samco Farma.

What other companies were previously penalized before PT Samco Farma and PT Ciubros Farma?

Three other pharmaceutical companies, namely PT Yarindo Permatama, PT Universal Farma Curicle Industries, and PT Afifarma, were penalized before these two companies.

What types of solvents are affected by the production halt?

The production halt affects all products using solvents such as propylene glycol, polyethylene glycol, sorbitol, and glycerol.

What is the next step for PT Samco Farma and PT Ciubros Farma regarding their syrup medications?

They must stop the production and distribution of syrup medications until further developments arise from testing and examination.

How did BPOM respond to the findings of contamination?

BPOM took immediate action by ordering the withdrawal of the contaminated syrup medications from circulation and overseeing their destruction.