Teva Pharmaceutical Industries ($TEVA), which in April had to recall a children's growth hormone, has now halted production of a parenteral nutrition product as the authorities try to determine why 9 children in Israel developed blood infections after taking it.
Israel's Health Ministry is investigating Teva manufacturing process and looking at the product ingredients, and the tubing and other equipment for sterility issues to track down the source of the infections, Haaretz reports. Teva is looking at setting up an alternative line to continue to produce the product. The children, aged two months to 5 years, have been treated with antibiotics for the pantoea infection. All are in good condition and some have already been released from the hospital, Haaretz reports.
In an emailed statement today, the company said, "Teva Medical is cooperating fully with the Ministry of Health (MoH) in the review of the matter. The company has conducted extensive inquiries to identify the source of the problem and will provide an update as soon as it has information other than that provided by the MoH."
Teva, the world's largest generics maker, has had a number of recall issues lately. In April, Ferring Pharmaceuticals of Parsippany, NJ, voluntarily recalled 8 lots of Tev-Tropin, Teva's somatropin human growth hormone product, made in Israel. The recall notice said the injectable product may have been contaminated by silicone oil leaking into it during the freeze drying process. The recall involved 129,060 cartons.
That was the same month that Teva recalled more than 1 million bottles of its version of Eli Lilly's ($LLY) blockbuster Cymbalta antidepressant which it had only been selling for a few months. Teva recalled 19 lots of the extended-release version of duloxetine, all manufactured in Israel, because of a customer complaint about capsule breakage. The total recall added up to 1,050,266 bottles. The company said at the time that it had figured out the root cause of the problem and that the recall would have no material impact on the company.
- read the Haaretz story (sub. req.)