Alerts

We have investigated 2 serious adverse event cases in young babies who had EMLA (prilocaine/lidocaine cream) applied to their skin for local anaesthesia. Both cases were likely to have involved overdose.

TGA is issuing a safety advisory about the importation of unregistered GLP-1 products that are being promoted online for weight-loss.

We are issuing a safety advisory regarding imported unregistered melatonin products following testing by TGA Laboratories.

Our investigation into concerns about Vyvanse’s potential lack of effectiveness, quality and safety found no issues of concern.

Consumers are advised that several sunscreen products are being recalled by sponsors. This follows preliminary testing evidence indicating that the SPF levels of their products may be lower than what is claimed on their labels.

We are issuing a safety advisory about the increasing importation and use of unregistered oral methylene blue (methylthioninium chloride) products in Australia.

Stryker is conducting a Critical Product Correction of Pad-Paks used with the HeartSine samaritan Public Access Defibrillator (PAD), with an expiry date range between 17 April 2025 to 01 August 2029.

Product correction and Product alert. This update includes new information regarding the software correction, actions for healthcare professionals and inclusion of the single chamber (SR) pacemaker.

We continue to receive reports of lead poisoning linked to imported or unregistered Ayurvedic medicines contaminated with heavy metals.

Grace & Fire Pty Ltd (trading as Ultra Violette) is recalling all batches of Ultra Violette Lean Screen SPF 50+ due to inconsistency in the SPF level of the product.

Star Combo Australia Pty Ltd is recalling multiple batches of four Living Healthy High Strength Gummies products due to non-compliant labelling.

Product Alert: Australasian Medical & Scientific Ltd (AMSL), the sponsor of the t:slim X2 insulin pump, has identified that certain versions of the device have a wiring problem with the speaker.

Baby deaths have been associated with home use of foetal heart monitors, which can give false reassurance and should not replace assessment by a qualified healthcare professional.

Invacare Australia is updating the Instructions for Use (IFU) of the Birdie Lifter and Compact Lifter. Users need to be aware of the correct position for the carabiner and the correct attachment of the hanger bar.

Homart Pharmaceuticals Pty Ltd is recalling specific batches of its product, SpringLeaf Fat Clear, due to two identified compliance problems.

Consumers and health professionals should be aware that two unrelated cases of counterfeit injectable botulinum toxin products have been stopped at the Australian border.

Well Herb is recalling batch numbers: DB0014M & DB0015M with expiry Date 11/12/2027 supplied in Australia of Xinyi Biyan Pills due to the medicine having unacceptable amounts of lead above the permitted daily dose.

Due to ongoing problems with their A30 and A40 series BiPAP devices, Philips is now contacting those affected to organise replacement devices or discuss alternative options.

Consumers and health professionals should be aware that examples of counterfeit products have been stopped at the Australian border. These tablets may pose a serious risk to your health and should not be used.

Consumers and health professionals should be aware that examples of counterfeit Roche labelled products have been stopped at the Australian border.

The Therapeutic Goods Administration are continuing to see imports of counterfeit ivermectin.

Consumers and health professionals should be aware that examples of substandard Fitaro semaglutide pre-filled syringes have been stopped at the Australian border.

Stryker is conducting an Urgent Recall of certain serial numbers of the HeartSine Defibrillators.

Nhan Sam Tuyet Lien Truy Phong Hoan capsules pose a serious risk to your health and should not be taken.

Pentavite Pty Ltd is recalling two batches of Pentavite Multivitamin + Iron Kids Chewables because the product is missing required warning statements on the label.