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Recent changes

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TGA Seizes 57,000 Illegal Vaping Goods in NSW Crackdown

The Therapeutic Goods Administration (TGA) in Australia, with law enforcement support, seized over 57,000 illegal vaping products in Burwood, NSW. This action targets the illicit supply of vapes, with significant penalties including fines and imprisonment for non-compliance with the Therapeutic Goods Act 1989.

Priority review Enforcement Consumer Protection
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TGA Safety Advisory: Counterfeit GLP-1 Weight Loss Products

The Therapeutic Goods Administration (TGA) has issued an updated safety advisory regarding counterfeit weight loss products falsely claiming to contain GLP-1 receptor agonists. Laboratory testing confirmed these products contain no active GLP-1 ingredients and are not included in the Australian Register of Therapeutic Goods.

Priority review Notice Product Safety
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TGA Safety Alert: Natures Valley Collagen Builder contains undeclared sildenafil

The Therapeutic Goods Administration (TGA) has issued a safety alert regarding Natures Valley Collagen Builder tablets, which were found to contain undeclared sildenafil. Consumers are warned that the product poses a serious health risk and should not be taken.

Urgent Notice Product Safety
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TGA Safety Alert: Counterfeit Botox Vials Continue to be Imported

The Therapeutic Goods Administration (TGA) has issued a safety advisory regarding the continued importation of counterfeit Botox vials into Australia. These products, packaged to appear genuine but confirmed as fake by AbbVie, pose significant public health risks and cannot be legally imported under any circumstances.

Priority review Notice Pharmaceuticals
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TGA Safety Alert: Ayurvedic Tablets Contain High Heavy Metals

The Therapeutic Goods Administration (TGA) has issued a safety alert regarding Kumar Kalyan Rasa tablets, an Ayurvedic medicine. Testing revealed extremely high concentrations of heavy metals, including mercury, lead, arsenic, and cadmium, posing serious health risks to consumers, particularly pregnant women and children. The TGA urges consumers to exercise extreme caution with such products.

Urgent Notice Product Safety
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Safety Concerns Over Imported Counterfeit Melatonin Products

The Therapeutic Goods Administration (TGA) has issued a safety advisory regarding imported counterfeit unregistered melatonin products. Laboratory testing revealed significant discrepancies in melatonin content, with some products containing over 400% of the labelled amount and others none at all, posing serious risks to consumers, especially children.

Priority review Notice Product Safety
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Voxzogo (vosoritidum) Packaging Text Error Identified

Swissmedic has identified a packaging text error on Voxzogo (vosoritidum) outer packaging. The incorrect dosage information was printed on specific batches, and affected batches have been identified. The company has issued an information letter detailing the error and corrective actions.

Priority review Notice Pharmaceuticals
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Cytosar (cytarabinum) Barcode Expiry Date Discrepancy Alert

Swissmedic has issued a Health Professional Communication regarding a barcode expiry date discrepancy for Cytosar (cytarabinum) 2g/20ml, batch CT32407B. The date encoded in the 2D barcode on the vial label is incorrect and does not match the legible expiry date printed on the vial.

Priority review Notice Pharmaceuticals
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Yttrium Citrate (90Y)-YMM-1 Failed Sterility Test

Swissmedic has issued a communication regarding Citrate d'Yttrium (90Y)-YMM-1, Suspension for Injection, batch Z008. The batch failed its sterility test after incubation. While no immediate patient danger is expected, affected patients require close monitoring.

Urgent Notice Pharmaceuticals
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Keppra (Levetiracetam) Syringe Change and Medication Error Risk

Swissmedic and UCB-Pharma AG are issuing a communication regarding a change in the application syringe for Keppra (Levetiracetam) oral solution. A new 5 ml syringe replaces the 3 ml syringe for children aged 6 months to 4 years, requiring healthcare professionals to inform caregivers about the change and proper dosing to prevent medication errors.

Priority review Notice Pharmaceuticals

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57 monitored sources

Health Canada Recalls & Safety Alerts

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FDA Warning Letters

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MHRA Guidance & Safety

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CPSC Product Recalls

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FDA Guidance Documents

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FDA Recalls & Safety Alerts

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HHS OIG Reports & Publications

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FDA MedWatch Safety Alerts

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EMA News

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HSA Singapore Announcements

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NICE Technology Appraisals

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USP Compendial Notices

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NICE Highly Specialised Technology Evaluations

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ANSM France News

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TGA Australia Safety Alerts

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TGA Australia Media Releases

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TX Board of Pharmacy News

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PIC/S Publications & Updates

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FDA Novel Drug Approvals

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Canada Health Canada Drug Announcements

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ANSM Drug & Device Safety Alerts

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BfArM Drug Safety Communications

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AIFA Drug Safety Signals

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MA Pharmacy Practice Resources & Guidance

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CA Board of Pharmacy News

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VA Board of Pharmacy Newsletters

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ECHA News

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FDA Drug Recalls

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EDQM Press Releases & News

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NIH Policy Notices

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WHO Pharmaceutical Standards

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Swissmedic Health Professional Communications

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FDA Clinical Trials Guidance

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CMS Newsroom

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FDA Import Alerts

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ICH Guidelines News

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AMA Press Releases

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MHRA Drug & Device Alerts

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WHO News

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PMDA Japan Drug Precaution Revisions

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DEA Press Releases

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FDA Medical Device Recalls

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EMA CHMP Agendas & Minutes

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DEA Public Safety Alerts

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EMA News

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MHRA Publications

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TGA Australia Safety Alerts

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FDA Drug Safety Communications

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