Alerts

Information about the shortage of some antibiotics, including amoxicillin and metronidazole medicines

To assist with timely access for patients using amoxicillin, the TGA has made a Serious Scarcity Substitution Instrument (SSSI).

Aidacare Pty Ltd - Aspire Superlite Adjustable Seat Walker - Consumer Level Product Defect Correction - Securing nut incorrectly assembled

Safety alert relating to CPAP and BiPAP face and nasal masks that contain magnets which may cause active implantable devices to malfunction

Recall of one batch of Vicks VapoRub Xtra Strong 100g (AUST L 372739) which has been incorrectly labelled as Vicks Vaporub ointment

Product Defect Alert - Unclear instructions may result in overdose of boron

Insulet Australia Pty Ltd has received reports of problems with the Omnipod DASH Personal Diabetes Manager (PDM). These include battery swelling, fluid leaking from the battery and in rare cases, extreme overheating which may pose a fire hazard.

Update on Trilogy 100 Ventilators

BEWARE - Health supplements containing vitamin B6 can cause peripheral neuropathy

Recall of JSHealth Vitamins listed medicine Detox + Debloat.

Philips Respironics patient interface devices (face and nasal masks) with magnetic clips - New warnings

Update on BiPAP settings issues and recall progress

Breast implants (all alerts)

On 8 September 2022, the US Food and Drug Administration issued a safety communication about reports of squamous cell carcinoma and various lymphomas located in the capsule or scar tissue around breast implants.

Safety advisory - low levels of contamination with a nitrosamine impurity

The TGA received advice about high levels of lead and other heavy metals in the Ayervedic medicine named Penisole.

TRIKAFTA tablets may be incorrectly located in their pack (wallets).

There remains an increased global demand for semaglutide products which is impacting availability and certainty of supply of Ozempic (semaglutide) in Australia until early 2023.

Recommendations for clinicians to implement conservation methods no longer necessary as shortage is resolved.

The shortage of Metalyse (tenecteplase) is now resolved.

The TGA is investigating potential contamination of quinapril medicines with low levels of nitrosamine impurity

Statement update

Safety warning for consumers

The TGA has become aware of instances where patients have become falsely reassured by the home use fetal dopplers and delayed medical attention.

Microbial contamination in several batches of Lucas' Papaw Ointment