Details of the recall were published by Australia’s Therapeutic Goods Administration (TGA) after blister pack sheets containing other medicines were found to have been substituted into several packs of Valium (diazepam) 5 mg tablets.
Roche spokeswoman Simone Oeschger told this publication the Swiss pharma firm was presented with evidence of tampering on May 25 which it immediately shared with the TGA.
“Roche, in consultation with the TGA and our distribution partner, Apotex, issued an Urgent Medicine Recall to retrieve all Valium 5mg tablets in Australia on 26 May 2017,” she said.
“Specifically, there may be missing blister strips of Valium and/or substitution of a stolen strip with other medicines within the packs. At this time Roche is aware that substituted medicines may include – but may not be limited to – BTC Paracetamol Codeine tablets, BTC Rosuvastatin 10 mg tablets and Apotex-Pantoprazole 40 mg tablets.”
As such the TGA has also recalled batch number 40970 of Apotex’s BTC Paracetamol Codeine tablets, batch number F4250 of Apotex’s BTC Rosuvastatin 10 mg tablets, and batches of Apotex’s Pantoprazole 40 mg and 20 mg tablet, due to concerns of them being dispensed with missing blister sheets.
A batch of Sanofi-Aventis’ Stemetil (prochlorperazine maleate) has also been recalled for the same reason.
Supply chain tampering
According to Oeschger, the problem lies not with the manufacturing but with the supply chain, and is working closely with the TGA, Apotex and its third-party distribution firm Symbion Contract Logistics.
“Roche is confident that tampering occurred after the Valium 5 mg stock was shipped from the Roche warehouse in Australia. Symbion Contract Logistics is investigating the matter with law enforcement authorities.”
She added evidence of tampering had been found only in a small number of blister packs.
“At this stage we are aware of only 9 packs at the pharmacy level where this has occurred. To put this in perspective, 30,000 packs per month are distributed to pharmacies.
“However, as we do not yet understand the full extent of the tampering, we have made a decision to recall all batches of Valium tablets [in Australia] in the interest of patient safety.”
According to Australian news site Abc.net, Symbion released a statement saying they had sacked a worker at its Sydney-based distribution facility in relation to this matter.
Symbion was not immediately contactable by phone at the time this article was published to confirm this.