Product Recalls

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ACCC Info Centre: 1300 302 502

See www.recalls.gov.au for Australian Product Recall Information

Name: Ultra Nature Selancy Women 100 Gel Capsules

Date: 11/03/24

Batch number 81032, Expiry date: Feb 2026

Batch number 87908, Expiry date: May 2026

Problem:

1. The primary pack contains more than the allowable 750mg of iron as per the specific requirements for iron ( I ) glycinate under Item 2719 in Schedule 1 of the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2023. As a result, only packs of 31 capsules or less are allowable as unscheduled medicine.

2. As per most gelatin capsules, the Gelatin contains traces of sulfites or sulfur dioxide as a residue used as a preservative. Pursuant to Schedule 1 of the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, presence of sulfites in a medicine must be declared on the label of the medicine. Please note that the medicine's label does not include the statement 'Contains Sulfites'. However, a warning regarding sulfites is noted under the product description on the Ultra Nature website.

There is a risk of iron overdose and subsequently iron poisoning with an increased amount of capsules in primary packaging. Gastrointestinal symptoms would be the most common sign of iron poisoning, although may result in organ failure.

Allergic reactions to sulfites in gelatin are comparatively rare. However, exposure to sulphites has been reported to induce a range of adverse clinical effects in sensitive individuals, ranging from dermatitis, urticaria, flushing, hypotension, abdominal pain and diarrhoea , asthmatic reactions to life-threatening anaphylactic which is very rare. Asthma symptoms are the most common adverse reactions caused by sulfites. It's worth noting that sulfites allergy is very different from both Sulfur and sulfomaide antibiotics allergy (www.allergy.org.au).

Name: Spiriva Respimat® Solution for Inhalation 2.5μg

Date: 31/01/24

Batch number E96634, Manufacturing date: OCT 2022, Expiry date: OCT 2025

Batch number E63130, Manufacturing date: DEC 2022, Expiry date: DEC 2025

Batch number E61076 (Samples), Manufacturing date: NOV 2022, Expiry date: NOV 2025

Problem:

Spiriva Respimat is used for the maintenance treatment of chronic obstructive pulmonary disease (COPD) (including chronic bronchitis and emphysema) and asthma. It is sold as an inhalation solution in an inhaler device that counts the doses provided, up to a maximum of sixty doses.

Boehringer Ingelheim Pty Ltd is advising customers of a problem with some batches of this medicine. There have been reports of the dose counter stopping after the 10th dose and not locking after the 60th dose.

The dose counter is still functional, and the device will continue delivering doses after the 10th dose, but the counter does not move any further. It remains as showing only 10 doses delivered.

If you experience this problem, do not stop using your medicine. The Respimat device will continue to deliver the approved dose of your medication. The product is not being recalled, as this would lead to a shortage in the market. However, health professionals and patients need to be aware of this problem to ensure safe use and avoid harms.

Name: Henry Blooms Herb‐a‐lax 200g Dried Herb

Date: 19/01/24

AUSTL L 23408

Batch number 22108402, Expiry date: Apr 2025

Batch number 22108403, Expiry date: Apr 2025

Problem:

Phytologic Holdings Pty Ltd, following consultation with the Therapeutic Goods Administration, is recalling batch 22108403 and batch 22108402 of Henry Blooms Herb-a-lax 200g dried herb (which is a dried herb product to promote bowel regularity and relieve constipation) because insect contamination has been found in some bottles of this batch.

No other batches of Henry Blooms Herb-a-lax 200g dried herb are affected by this recall. If you have a bottle of Henry Blooms Herb-a-lax 200g dried herb from batch 22108403 and batch 22108402, do not use it. Return it to the place of purchase for a refund or call our customer service line to arrange the return of the affected product and refund.

CUSTOMER SERVICE 02 9700 8850

The insect was identified as Tobacco beetles, which may lead to food spoilage and potential digestive distress. Anyone who is concerned in any way about the use of this product should consult their doctor.

Name: Aerowash Eyewash and Wound Irrigation Ampoules

Date: 21/12/2023

Link: https://www.tga.gov.au/safety/product-recalls/recall-aerowash-eyewash-and-wound-irrigation-ampoules

Batch numbers: These ampoules are supplied both individually and as part of Aero branded and custom made first aid kits.

15ml ampoules

23136001E, 23136002E, 23136003E, 23136004E, 23136005E, 23136006E, 23136007E, 23136008E, 23136009E, 23136010E, 23136011E, 23136012E, 23136013E, 23136014E, 23136015E, 23136016E, 23136017E, 23136018E, 23136019E, 23136020E, 23136021E, 23136022E, 23136023E, 23136024E, 23136025E, 23136026E, 23136027E, 23136028E, 23136029E, 23136030E, 23136031E, 23136033E, 23136034E, 23136035E, 23136039E, 23136048E, 23136049E

30ml ampoules

2386019E, 2386020E, 2286033E

Problem: Following the recall of several sodium chloride ampoules manufactured by Legency Remedies Private, preliminary testing indicates the presence of Ralstonia pickettii in additional saline products from the same manufacturer. As a precaution, Aerowash Eyewash and Wound Irrigation ampoules are now being recalled from the Australian market. R. pickettii is a bacteria commonly found in the natural environment. It rarely causes infection in humans but may cause infection in people with weakened immune systems.

If you have any of the above products, do not use them. The batch number can be found on the ampoule label itself, below the product expiry.

Return the product to your place of purchase for a refund or contact the sponsor to arrange a refund.

Name: Designs for Health ProbioSpore

Date: 06/12/23

AUSTL: 396036

TGA Reference number: RC-2023-RN-01038-1

Batch no: 230229

Problem: Mandatory warning statements were found to be absent from the label of one batch of Designs for Health ProbioSpore. The absent warnings pertain to consumers using this product to improve bowel regularity and advised users to drink plenty of water and not to use the product when abdominal pain, nausea or vomiting are present or if you develop diarrhoea. The warnings also advised that if you are pregnant or breastfeeding, you should seek the advice of a healthcare professional before taking this product.

Macro Seed Mix 250g

Date: 01/12/2023

Reference number: W10710

Problem: Labelling issue

Name: BioCeuticals Zinc Drops (50mL)

Date: 10/11/23

Link: https://www.bioceuticals.com.au/education/article/urgent-medicine-recall

AUSTL L 388073

Batch numbers: 004766, 004807

Problem: Two impacted batches, numbers 004766 and 0047807, have been identified to have a uniformity / homogeneity issue due to zinc sediments in the product, which may provide inconsistent dosage even when used in accordance with the label instructions. This product is indicated for use for children 1 years of age to adults.

Inconsistent dosing may not provide the intended product benefits or may cause potential adverse effects. Taking a lower dose may not provide the intended product benefits. Taking a higher amount of zinc in a single dose or over a short period of time can cause zinc toxicity. This may result in symptoms such as nausea, vomiting, stomach pain, diarrhoea or headache. If consumers have an adverse experience from the product or they have any concerns, they must seek immediate medical attention.

If left untreated, large amounts of zinc may be dangerous and result in severe health issues which you can discuss with your healthcare practitioner.

Products in the affected batches do not meet the label claim and, in the interests of consumer health and safety, BioCeuticals is recalling these batches.

Ethical Nutrients Mega Magnesium Raspberry

Date: 18/10/23

Link: https://www.tga.gov.au/safety/product-recalls/recall-ethical-nutrients-mega-magnesium-raspberry-powder

Batch: 007764

Problem: Due to a manufacturing error, the pyridoxine content is twice the amount stated on the label. This means that it slightly exceeds the 100mg maximum recommended daily dose. Ingestion of excessive pyridoxine may cause tingling, burning and numbness.

11 September 2023

Euky Bear (Warm Steam) Vaporiser

Brand: Euky Bear (Warm Steam)

Reason: Felton Grimwade & Bosisto's Pty Ltd. in consultation with the Therapeutic Goods Administration, is recalling batches of Euky Bear (Warm Steam) Vaporiser due to a quality issue whereby the enclosed heating element can overheat. The batch number can be found on the base of the box or on the underside of the blue heating module (next to the power cord)

Affected: 230301, 231101, A231101, B231101

ARTG 297553

28 February 2023

Pholcodine cough medicines cancelled by the TGA

Following a safety investigation by the Therapeutic Goods Administration (TGA), 55 products containing pholcodine are being cancelled from the Australian Register of Therapeutic Goods and those currently on pharmacy shelves are being recalled from pharmacies

For more information please visit the TGA website.