Teva growth hormone for children recalled after oil leaks into product

Israel-based Teva Pharmaceutical Industries ($TEVA), in the midst of restructuring its manufacturing network, has faced a number of recalls of late. Now a New Jersey company is recalling nearly 130,000 cartons of Teva's human growth hormone for children because there is a chance that oil leaked into it.

According to the FDA enforcement report, Ferring Pharmaceuticals of Parsippany, NJ, is voluntarily recalling 8 lots consisting of 129,060 cartons of Tev-Tropin, Teva's somatropin product, made in Israel. The report says the injectable product may have been contaminated by silicone oil leaking into it during the freeze drying process. The nationwide recall was initiated at the end of April.

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.

It also had to recall nearly 258,000 cylinders of Qvar, which it does not manufacture itself. According to the recall notice, the inhaled asthma drug is manufactured for Teva by 3M Drug Delivery Systems of Northridge, CA. They were voluntarily retrieved because the drug failed stability testing for impurity and degradation specifications at both the 9-month and 18-month time periods. Qvar is a substantial seller for Teva with 2013 revenues of $463 million, up 2%.

Teva is going through a major restructuring as it works to cut about $2 billion in costs. Its manufacturing network is being substantially pared to help achieve those cuts. CFO Eyal Desheh last month told analysts that Teva intends to close roughly half of its 75 plants in the next four to 5 years. That is being done even as it builds some new facilities in faster growing markets like Russia.

- here's the FDA enforcement report