A distribution center in Sydney, Australia, has become the focus of a drug-tampering investigation that has led Roche to recall all of its 5-mg Valium blister packs in the country and that will result in a short-term supply disruption there.
A Roche spokesperson said today that after receiving evidence of the supply chain breach last week it immediately reported the problem to Australia’s Therapeutics Goods Administration which issued a recall for the Valium. So far there have been no reports of adverse reactions.
“Specifically, there may be missing blister strips of Valium and/or substitution of a stolen strip with other medicines within the packs,” Roche Media Spokesperson Simone Oeschger said in an email.
Police have been called in to investigate and ABC News in Australia reported today that Roche distribution partner Symbion Contract Logistics released a statement saying it had dismissed a worker at its Sydney-based facility that handles distribution of the products. .
The recall and probe started after Roche discovered that nine Valium blister pack sheets had been substituted with those of other drugs, including Apotex paracetamol codeine tablets, rosuvastatin tablets and pantoprazole tablets, as well as prochlorperazine maleate tablets from Sanofi. The TGA also recalled those products.
Oeschger said the nine blister packs are out of the 30,000 packs per month that the company distributes to pharmacies in the country. But because but because the company doesn’t yet know the full extent of the problem, she said, Roche recalled all batches of the product in the country in the interest of safety.
Oeschger said the company is confident that the tampering occurred after the Valium left the Roche warehouse in Australia. Roche is working with the TGA, distribution partner Apotex and its logistics operator Symbion Contract to investigate the supply chain breach.
Because of the ongoing investigations, a temporary hold has been place on Valium supply in Australia which Oeschger said will mean a short-term disruption of supply. Pharmacists will arrange for an alternative medicine to be dispensed.
While rare, drug tampering can be very disruptive for drugmakers. In 2015, CDMO Catalent had to suspend production for six months at a softgel plant in France while authorities investigated tampering that the drugmaker had uncovered at the facility. The episode contributed to a 2% drop in revenues for Catalent in the first quarter of last year.