2,938 changes Notice, last 7 days
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.
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.
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.
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.
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.
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.
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.
ANSM Ensures Continuity of Emend 125 mg Oral Suspension for Children
The ANSM has announced measures to ensure the continuity of treatment for children using Emend 125 mg oral suspension due to supply difficulties. Prescribers are advised to reserve the oral suspension for specific pediatric cases and explore alternative formulations for older children and adults. Importations are being arranged to cover demand.
Doliprane Suspension Recall Due to Pipette Wear-Off
The French Agency for the Safety of Medicines and Health Products (ANSM) has announced a recall of 27 lots of Doliprane 2.4% oral suspension due to a manufacturing defect causing pipette graduations to wear off. This defect poses a risk of incorrect dosage and potential overdose in infants and young children.
ANSM Warns of Significant Risks from Off-Label Isotretinoin Use
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a warning regarding the off-label promotion and use of isotretinoin-based medications for aesthetic purposes on social media. The agency emphasizes that these drugs are strictly indicated for severe acne and carry significant risks, including psychiatric disorders and birth defects.
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