Name: Caruso’s Natural Health WEE LESS, BLOAT EZE and ASHWAGANDHA 7500

Date: 10 December 2024

Batch numbers:  

WEE LESS, Q01661. Expiry September 2027

BLOAT EZE, Q01518, Q01516. Expiry May 2027

ASHWAGANDHA, Q01687. Expiry September 2027

Problem:

The composition of these unknown capsules has not yet been determined, so the risk that they pose is currently unknown. However, from a preliminary investigation, it appears the unknown capsules could contain cocoa powder and probiotics. As the potential for these unknown capsules to cause harm cannot be ruled out, Caruso’s Natural Health Pty Ltd has decided to recall the affected batches and is currently investigating this problem further. This recall does not affect any other batches of WEE LESS, BLOAT EZE and ASHWAGANDHA 7500.

What should you do?

If you have purchased these batches of Caruso WEE LESS, BLOAT EZE or ASHWAGANDHA 7500, do not use it. Return the product to the place of purchase or contact customer service.

For more information, please refer to the recall alert.

Name: Nature's Way Hair Growth Support +Biotin & Silicon tablets 30's pack size

Date: 09/12/2024

Batch numbers: (B) 3227 expires in June 2025, (B) 3298 expires in July 2025, (B) 3415 expires in September 2025, (B) 3483 expires in October 2025, (B) 3577A and (B) 3577B both expire in January 2026, (B) 3853 expires in February 2026, (B) 3638 expires in March 2026, (B) 3785 expires in August 2026, and (B) 3861A also expires in August 2026.

Problem:

The bottle is missing a child resistance closure. Only the 10 batches listed are affected.

What is the hazard/risk?

Due to the absence of a child resistant closure the product may pose a low risk of accidental ingestion of more than the dosage directed on the label especially by children.

There is no impact on safety, quality and efficacy when the product is taken as directed on the label by adults.

What should you do?

Please inspect your stock immediately and quarantine all units for the Nature's Way Hair Growth Support + Biotin & Silicon tablets 30's pack (Product Code 523269 or AUST L320004) from the above affected batches. Only the 10 batches listed are affected.

Please complete the attached Customer Response Form by 16 December 2024, even if you do not have any stock from these batches and return it to customerservice@pharmacare.com.au or

Fax (02) 9997 1698, as we require this information to reconcile this process and to fulfill our obligations with the TGA.

After returning the form, you may destroy the stock, and a credit note will be issued. Please ensure that you dispose all affected stock responsibly and provide evidence of disposal i.e. photo of the full quantity disposed with barcode defaced on each bottle to enable the issuance of a credit note.

Please ensure relevant staff members are informed of this Retail Level Recall.

If any of the recalled stock could have been transferred from you to another business, please immediately let them know of the recall and provide that business with a copy of this letter immediately.

This recall does not affect any other batches of product or any other Nature's Way product(s).

How will this be resolved?
PharmaCare has already corrected this problem,and all new stock has a child resistant closure and is available to order.

Please contact us to arrange for replacement product.

Retailers should note that no other batches of this product are affected.

Contact Information

For questions regarding this letter, please contact:

Customer Service Manager PharmaCare Laboratories Pty Ltd customerservice@pharmacare.com.au Phone number (02) 9997 0355

Name: Panadol Children 1 Month - 1 Year

Date: 30/04/24

Batch numbers: DR562, DR563, DT528, DS947, DS956, DT334, DT469, DT762, DT912, 

DU128, DT913, DW301, DW507, DW487, Expiry date: Feb 2025

Problem:

Haleon is issuing a Product Defect Correction for the above-mentioned batches of PANADOL CHILDREN 1 MONTH – 1 YEAR paracetamol 100 mg/mL oral liquid bottle (which is used for the temporary relief of pain and fever) due to difficulties that may be experienced when using the supplied dosing syringe. There is no concern around the liquid medicine itself. 

The component impacted is the dosing syringe. The dosing syringe in the affected batches may experience stiffness impacting the ability to control the delivery of the medicine to babies which may pose a risk of choking in babies.  No other batches of this product, or other Panadol Children products, are affected. 

If you have PANADOL CHILDREN 1 MONTH – 1 YEAR paracetamol 100 mg/mL oral liquid bottle from the batches listed above, dispose of the supplied syringe, and seek an alternative dosing syringe from your pharmacy. Dosing syringes printed with “Panadol” are not impacted. 

You can contact Haleon Consumer Relations on 1800 028 533 from 8:30am – 5:00pm weekdays, Eastern Standard Time. 

Anyone who is concerned in any way about the use of this syringe should consult their pharmacist.

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.

09 November 2022

Brand: Protein Bread Company Pty Ltd

Reason: The affected batches may be contaminated with the presence of an undeclared allergen (soy)

Affected: 

PBCO. Protein Pancakes Mix Plant Protein 300g; 

Batch;

9849-03- Best before 26/11/2023

9849-03- Best before 26/11/2023

 9849-02- Best before 26/11/2023

 9849-02- Best before 6/11/2023

11 October 2022

A’kin Mild & Gentle Shampoo Fragrance Free & Hypoallergenic 500ml

Brand: A’kin

Reason: The affected batch may be contaminated with bacteria (Enterobacter Gergoviae)

Affected: UPC 9318329010558 A’kin Mild & Gentle Shampoo Fragrance Free & Hypoallergenic 500ml

11 February 2022

IQ Bars

Brand: IQ Bars

Reason: To enable a labelling adjustment to clarify the possible presence of milk allergens.

Affected:

UPC 850004554029 IQ Bar - Chocolate Sea Salt 45g (BB June 10 2022)

UPC 850004554005 IQ Bar - Peanut Butter Chip 45g (BB June 11 2022)

UPC 850004554012 IQ Bar - Almond Butter Chip 45g (BB Apr 14 2022)