Tenofovir Disoproxil Emtricitabine Mylan 300/200 Tablets
AustraliaTenofovir Disoproxil Emtricitabine Mylan 300/200 Tablets
Reason for Recall / Hazard
TranslatedPotential for broken and/or split tablets. In the event a broken/split tablet is consumed, this may result in an ineffective dose if the tablet is not taken in its entirety.
Product Description & Identification
TranslatedReason / Defects: Potential for broken and/or split tablets. In the event a broken/split tablet is consumed, this may result in an ineffective dose if the tablet is not taken in its entirety. Hazards: A broken or split tablet may lead to ineffective dosing, which may increase the risk of adverse health effects. What to do: Consumers that have been prescribed Tenofovir Disoproxil Emtricitabine Mylan 300/200 should consult their treating physician for advice. Consumers that have any unexpired product should return the product to their pharmacist for a refund. A TGA web statement can be found at https://www.tga.gov.au/alert/tenofovir-disoproxil-emtricitabine-mylan-300200 For further information, please contact Alphapharm on 1800 274 276.
Affected Products
TranslatedTenofovir Disoproxil Emtricitabine Mylan 300/200 tenofovir disoproxil maleate 300 mg and emtricitabine 200 mg film coated tablets All batches within expiry ARTG: 265834 Prescription Medicine for: The treatment of HIV-infected adults over the age of 18 years, in combination with other antiretroviral agents. In combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | 9abe8c65-241c-4516-8195-9d9c056d85ea |
| Guid › @ is Perma Link | false |
| Link | https://www.productsafety.gov.au/search-consumer-product-recalls/tenofovir-disoproxil-emtricitabine-mylan-300200-tablets |
| Pub Date | Thu, 14 Jan 2021 00:00:00 +0000 |
| Extracted image | https://www.productsafety.gov.au/system/files/styles/large/private/Tenofovir%20Disoproxil%20Emtricitabine%20Mylan%20Bottle.jpg?itok=CgI_2K4R |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsCheck the model number, serial number, and date stamp on the rating label on the back or underside of the product.
Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Australia Products).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Tenofovir Disoproxil Emtricitabine Mylan 300/200 Tablets?
Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (Australia Products). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Overview
- Risk LevelPharmacy and medical products
- DistributionAustralia
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🚨 SAFETY ALERT: Tenofovir Disoproxil Emtricitabine Mylan 300/200 Tablets Check if your household is affected: https://therecallfile.com/recalls/tenofovir-disoproxil-emtricitabine-mylan-300-200-tablets/AU-9abe8c65-241c-4516-8195-9d9c056d85ea
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