Counterfeit Alprazolam 2mg tablets and counterfeit Kalma 2 tablets pose a serious risk to your health and should not be taken.
In conjunction with NSW and QLD health, the Therapeutic Goods Administration (TGA) has investigated reports of counterfeit Alprazolam in community circulation. Testing of a number of products labelled ‘Alprazolam 2mg’ and ‘Kalma 2’ has found that:
- The Alprazolam 2mg product is an attempted counterfeit of a genuine product in the international marketplace. Whilst this is a genuine product in the United States of America (USA), it is not supplied legally in Australia. The product does not have an AUST R number. Distinguishing features are outlined below.
- The Kalma 2 product is an attempted counterfeit of a genuine Australian product and is being illegally supplied.
- Counterfeit Alprazolam 2mg tablets and Kalma 2 tablets may contain a range of undeclared substances in different combinations and dosages. Undeclared substances that may be present include etizolam, cyproheptadine, promethazine, Flubromazepam, amantadine and MMTMP.
- Consumers are advised that substances contained within these goods may be classified as either prescription-only (Schedule 4) ‘Appendix D’ medicines, Controlled Drugs (Schedule 8) or Prohibited Substances (Schedule 9). Therefore, possession of these tablets may be illegal.
The supply of counterfeit Alprazolam 2mg tablets and counterfeit Kalma 2 tablets in Australia is illegal.
Information for consumers
- Information held does not indicate the presence of counterfeit products in pharmacies at this time.
- If you suspect the medication you are taking is counterfeit or you have obtained it without a prescription, stop taking it and take the packaging and any remaining tablets to your local pharmacy for safe disposal.
- If you have any concerns arising from your use of this product, consult your health care practitioner.
- The counterfeit tablets present with the following features, which differ from the genuine product. Examples of the genuine product and counterfeit can be viewed on the right.
- The number under the barcode on the side of the label does not match the ‘NDC’ number displayed on the front of the package at the top.
- The counterfeit Alprazolam 2mg product does not include a QR code with the Lot number, Serial Number and Expiry beside it (located near the barcode on the label of the genuine product).
- The counterfeit Kalma 2 product does not include the Manufacturers logo (Mylan).
Action the TGA is taking
The TGA is working with the Australian Border Force (ABF) to help stop any future shipments of counterfeit Alprazolam 2mg tablets from entering Australia.
If these tablets are found at the border by the ABF they will be seized and destroyed.
The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas Internet sites and has produced a short video on the risks associated with buying medicines and medical devices online. Products purchased over the Internet:
- may contain undisclosed and potentially harmful ingredients
- may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.
NOTE: Barcode number and front of label ‘NDC’ numbers match. QR Code and Lot/Expiry/Serial Number are present. This is the American version which is not supplied legally in Australia.
NOTE: Barcode number and front of label ‘NDC’ numbers DO NOT match. QR Code and Lot/Expiry/Serial Number ARE NOT present.
NOTE: The picture above is the current legally supplied version of Kalma 2, and has the manufacturer’s image on it (Mylan).
NOTE: The picture above is the counterfeit version of the Australian manufactured Kalma 2. The label is missing the manufacturer’s image.