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Valium (diazepam) 5 mg tablets in 50 tablet blister packs

Recall - potential medicine tampering

1 June 2017

Consumers and health professionals are advised that Roche Products, in consultation with the TGA, is recalling all batches of Valium 5 mg tablets supplied in blister packs of 50 tablets due to the discovery of evidence of medicine tampering.

These tablets contain diazepam, which is used to treat anxiety disorders, alcohol withdrawal symptoms and muscle spasms.

It has been identified that blister pack sheets containing other medicines have been substituted into some packs of the affected product. These medicines may include (but may not be limited to) BTC Paracetamol Codeine tablets, BTC Rosuvastatin 10 mg tablets, Apotex-Pantoprazole 40 mg and 20 mg tablets, and Stemetil 5 mg tablets.

If a patient has an affected pack, there is a risk that they will not have adequate supply of their medicine and could take the incorrect medicine, which could have serious health consequences.

The issue is currently being investigated in conjunction with the relevant authorities. However, it is believed that the tampering is not widespread.

Information for consumers

If you or someone you provide care for takes Valium 5 mg tablets supplied in 50 tablet blister packs, do not take them and please promptly return any unused medicine to a pharmacy for a refund.

If possible, you’re advised to return your tablets to the same pharmacy from which it was dispensed.

There are a number of generic diazepam products that are bioequivalent to affected products. They contain the same active ingredient and work in the same way, and in most situations can be safely substituted. If you have a valid prescription (this includes repeat prescriptions), the pharmacist may be able to provide you with an equivalent alternative.

Please note that all tablets or capsules supplied in a pack should be identical and any product names on the blister packs should match those on the external packaging. If you notice any discrepancies with your medicine, talk to your pharmacist.

If you have any other questions or concerns about this issue, talk to your health professional.

Information for health professionals

If you treat patients who take Valium, please be aware of this issue.

Roche Products has written to pharmacists providing further information about this issue, including details of the recall process. Please inspect your stock and quarantine all affected batches before returning them to your wholesaler.

Patients returning unused or partially used packs should be provided a full refund and, if possible, offered an equivalent generic product to ensure continuation of therapy and avoid any risks of discontinuation symptoms. A generic alternative can only be offered on presentation of a valid prescription, or emergency arrangements if allowed under your jurisdictional legislation. If affected product was dispensed under instructions by the prescriber to not substitute, you may need to contact the prescriber to discuss this issue. All stock returned to you by the patient must be returned to the wholesaler.

If you have any further questions or concerns about this issue, please contact Roche Products on 1800 233 950 (for general inquires).

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.