While answers about the testosterone shortage affecting brands in Canada and the U.S. have been hard to come by, we can now safely assume that Sandoz testosterone will remain unavailable for some time. Sandoz Canada announced Sunday it was temporarily suspending production at its Boucherville, Que., facility. The company said it was expecting “a significant reduction in output” and was halting production lines to upgrade operations after quality-control assessments by the U.S. Food and Drug Administration warned the factory fell short of FDA standards.
During inspections last summer, the U.S. regulator found the plant — along with two other Novaris/Sandoz plants in the States — had failed to prevent contamination in some drugs and did not alert the agency quickly enough. No products were recalled.
“In light of the November 2011 FDA Warning Letter, Sandoz Canada has further intensified its ongoing efforts to ensure high quality standards across its manufacturing operations. As part of these efforts, we will temporarily suspend or discontinue the production of certain products at our Boucherville site, most of which have alternatives in the marketplace, to prioritize production of most medically necessary products, and focus on the supply of critical medicines to the Canadian market.”
While Sandoz has not clarified which drugs will go out of production, this bulletin indicates that their 200mg/ml testosterone was discontinued in the U.S. in September 2011. Given the timing, the FDA crackdown may have been responsible for Sandoz testosterone becoming unavailable last fall. (A lack of raw materials has been cited by other testosterone manufacturers as the reason for the shortage.)
The latest slowdown comes amid a global shortage of several brands of testosterone, including Valeant, Pfizer and Sandoz in Canada; Paddock, Watson, Sandoz and Teva in the US; as well as Sustanon outside North America.
Rumored Return Dates For Canadian Brands of Testosterone
- Pfizer Depo-T (testosterone cypionate): mid-February or mid-March
- Sandoz (testosterone cypionate): May? Rumor was heard before this latest news about Sandoz.
- Valeant Delatestryl (testosterone enanthate): Unknown. Originally, Valeant claimed a mid-January return.
Have you heard any updates from your pharmacist lately? Please leave your comments below.