Showing notices 145–192 of 227.
Pharmacy and medical products(a) The elastic luggage straps do not have the required warning label in accordance with Consumer Goods (Elastic luggage straps) Safety Standard 2017. (b) The children’s toys contain batteries that can become accessible through normal use, which does not comply with Consumer Protection Notice No. 14 of 2003, as amended by Consumer Protection No. 1 of 2005. (c) The hot water bottles do not meet the performance, physical and labelling requirements in accordance with the Trade Practices (Consumer Product Safety Standard) (Hot Water Bottles) Regulations 2008.
Pharmacy and medical productsBlister pack sheets containing other medicines may have been substituted into some packs of Valpam 5mg tablets. These medicines may include (but may not be limited to) Amlodipine Sandoz 5mg tablets.
Pharmacy and medical productsThis medicine may have been dispensed with missing blister sheets.
Pharmacy and medical productsThis medicine may have been dispensed with missing blister sheets.
Pharmacy and medical productsThis medicine may have been dispensed with missing blister sheets.
Pharmacy and medical productsThis medicine may have been dispensed with missing blister sheets.
Pharmacy and medical productsThis medicine may have been dispensed with missing blister sheets.
Pharmacy and medical productsThis medicine may have been dispensed with missing blister sheets.
Pharmacy and medical productsBlister pack sheets containing other medicines may have been substituted into some packs of Valium 5mg tablets. These medicines may include (but may not be limited to) BTC Paracetamol Codeine, BTC Rosuvastatin 10mg tablets, Apotex-Pantoprazole 40mg or 20mg tablets and Stemetil 5mg tablets.
Pharmacy and medical productsThe products contain inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the products' labels.
Pharmacy and medical productsThis is a recall for correction of the packaging only. The bottles have been supplied with a cap that is not child-resistant. There is no concern regarding the quality or safety of this medicine.
Pharmacy and medical productsThere is a potential that these devices may contain a defective part that may result in the device failing to activate or requiring increased force to activate.
Pharmacy and medical productsAn out-of-specification (OOS) result has been recorded for povidone-iodine assay in one batch of the Difflam Sore Throat Ready to Use Iodine Gargle (povidone-iodine 10mg/mL) 200mL bottle. The OOS result for povidone-iodine assay occurs early in the product's shelf-life (2 months).
Pharmacy and medical productsMedtronic has identified a software issue that could prevent the internal battery from charging on some MiniMed 640G insulin pumps. If the issue occurs, an alarm is triggered and patients will see "Power error detected" and "25" displayed on the pump screen (power error 25). The message states "Delivery stopped. Record your settings by uploading to CareLink or write your settings on paper. See User Guide."
Pharmacy and medical productsProduct contains undeclared substances sibutramine and phenolphthalein.
Pharmacy and medical productsThe manufacturer has determined that a correction to the Adjuster Assembly part of the O2Vent T device is necessary and must be returned for rework. The Adjuster Assembly allows adjustment of the screw and hook for appropriate titration by mandibular advancement for optimised treatment.
Pharmacy and medical productsThe products may experience leakage caused by over welded coils, which can lead to difficulties in unrolling the tubing that can create pinholes in the lines. The damage may not be visible and will not be detected by the system's Sleep-Safe cycler.
Pharmacy and medical productsA correction to the Instructions for Use in relation to the adjustment range for titration is necessary.
Pharmacy and medical productsTesting of products from the affected batch has detected the presence of very low levels of aristolochic acid.
Pharmacy and medical productsIt has been identified that bottles of Dilantin have been supplied with child-resistant caps that may not engage or otherwise be properly secured.
Pharmacy and medical productsThe first aid instructions supplied are poorly written and cannot be relied upon in an emergency. Some of the information is unsuitable and not in line with Australian first aid protocols.
Pharmacy and medical productsThe products contain Asarum species, which have been documented to contain aristolochic acids. Asarum species containing aristolochic acid(s) for human therapeutic use are included in Schedule 10 of the Poisons Standard and are not permitted for use in therapeutic goods in Australia.
Pharmacy and medical productsSome products from the affected batch may contain a pathogenic organism, Staphylococcus aureus , commonly known as golden staph.
Pharmacy and medical productsSome batches of the products are contaminated with the bacteria Burkholderia cepacia .
Pharmacy and medical productsApotex Pty Ltd is recalling one batch of the APO-Cabergoline 500mcg tablets (batch MK0903, expiry date February 2017) due to a packaging issue, where the desiccant may not protect the product from moisture throughout its shelf life.
Pharmacy and medical productsPossibility of injection needle detaching from 1mL pre-filled solvent syringe.
Pharmacy and medical productsNutricia Australia has received overseas reports of the Flocare Infinity enteral feeding pump 'air in line' (AIL) alarm not always working when used with mixed or reconstituted powdered tube feeds. It is believed that undissolved particles can accumulate in the feeding line or form a film on the inner side of the tube around the pump sensors, which can interfere with the pump's air detection function.
Pharmacy and medical productsThe detachable wall plug could split, exposing a live metallic contact.
Pharmacy and medical productsResMed has received a number of reports regarding the performance of the internal battery in Astral 100 and Astral 150 ventilators. According to these reports, an internal electrical issue has led to ventilation stopping without either the 'low battery' or 'critically low battery' alarms activating as intended.
Pharmacy and medical productsIncorrect programming means that the products are not operating as intended and the affected pendant products will be unable to send an alarm upon activation of the button press mechanism; therefore cannot elicit a response from a designated responder.
Pharmacy and medical productsThe angle adjustment mechanism for James Leckey Design Mygo Standers manufactured during this period allows the user to lock out the frame’s safety pull pin and adjust the angle using one hand. If the operator’s hand slips off the turning handle when a patient is in the frame, the handle could ‘self-wind’ and spin rapidly as the stander returns to the upright position.
Pharmacy and medical productsIt has been identified that the pressure bar material in the affected batch may break during use.
Pharmacy and medical productsIt has been identified that some of the test strips from the affected batch may have been contained within an open test strip vial. Being exposed to the outside environment can affect test strip performance and lead to false low readings.
Pharmacy and medical productsThere is a possibility of a small quantity of particulate contamination in an ingredient that is used to manufacture the products listed above.
Pharmacy and medical productsThere is a possibility that the audible alarms may not work.
Pharmacy and medical productsThe recall is due to the potential that some bottles may contain at least one Plavix/Iscover (clopidogrel 75 mg) tablet.
Pharmacy and medical productsTGA testing of Mums The One one step hCG urine pregnancy tests from the affected batch found that these tests do not meet a claim made in the product documentation. Specifically, these tests failed to detect hCG at concentrations of 10 mIU/mL, 25 mIU/mL and 50 mIU/mL levels.
Pharmacy and medical productsSHEN NENG CHING FEI YI HOU PIEN (AUSTL 57184) was found by TGA Laboratories to be contaminated with Paracetamol. The content of paracetamol was estimated by LC/MS to be 9 mcg/g (9 ppm). This is below the SUSMP threshold limit of 10 ppm (10 mg/kg) for scheduling of paracetamol. However, paracetamol is not declared in the ARTG entry for AUSTL 57184 and is not approved for use in listed medicines.
Pharmacy and medical productsTGA testing of ConceivePlease one step hCG urine pregnancy test kits from the affected batch found that these kits do not meet a claim made in the product documentation. Specifically, these tests failed to detect hCG at concentrations of 25 mIU/mL levels.
Pharmacy and medical productsThe Therapeutic Goods Administration (TGA) has tested a product labelled Maxagra capsules and found that: •the capsules contain the undeclared substance sildenafil; and •the capsules contain the undeclared antibiotic substance oxytetracycline
Pharmacy and medical productsIt has been identified that B. Braun water for injections from this lot may leak due to cracks in the neck of the bottle, which could result in bacterial contamination.
Pharmacy and medical productsThe recall is due to a Microbial (Salmonella) contamination.
Pharmacy and medical productsThe recall is due to the presence of an undeclared allergen (fish).
Pharmacy and medical productsThere have been reports of ENFit transition adaptors, which are supplied in Australia as a component of Flocare transition giving sets, leaking and/or breaking.
Pharmacy and medical productsSome of HeartWare's AC adapters are vulnerable to power grid surges above 220 volts and, when affected, will automatically switch to a back-up power source (batteries). In addition, some HeartWare batteries supplied before December 2014 have the potential to lose their charge prematurely.
Pharmacy and medical productsThere is a risk of the bottle grooves breaking off when opening the bottle.
Pharmacy and medical productsThere is a risk of the bottle grooves breaking off when opening the bottle.
Pharmacy and medical productsThere is a risk of the bottle grooves breaking off when opening the bottle.