Sandoz Canada restarts shipments of 2mg/mL, 1 mL morphine ampoules with 100% product passing inspection

BOUCHERVILLE, QC, March 26, 2012 /CNW Telbec/ - Sandoz Canada announces it has completed its re-inspection of all quarantined inventory of Morphine Sulfate Injection USP 2 mg/mL, 1 mL ampoules and is starting first customer shipments of the visually inspected product, less than two business days following the recall. No additional boxes with Isoproterenol ampoules were found during re-inspection.

More than 10,000 boxes of the 2 mg/mL 1 mL product or the equivalent of more than 100,000 units were visually inspected over the weekend and are now being released, representing more than one month of the market need for this presentation. In parallel, Sandoz also increased allocations for its, in some cases, substitutable 10mg/mL product from 100% to 120%, as an additional precautionary measure to avoid a market shortage. All visually inspected product boxes have been clearly marked with a sticker and can be easily identified.

"We are pleased that Sandoz Canada has been able to ensure a quick turnaround of this visual inspection, allowing us to meet critical patient needs during this challenging period," said Sandoz Canada President Michel Robidoux.

Sandoz initiated a limited voluntary recall of a single lot of Morphine Sulfate Injection USP 2 mg/mL, 1 mL ampoules on March 23, due to a potential presence of ampoules of Isoproterenol HCl Injection USP 0.2 mg/mL in the morphine boxes. All ampoules found within the box were confirmed to be correctly labeled. Sandoz also informed all Healthcare Practitioners with a separate communication on March 24.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "potential" or similar expressions, or by express or implied discussions regarding the recall of one (1) lot of Morphine Sulfate Injection USP 2 mg/mL in 1mL ampoules or regarding potential future revenues from Morphine Sulfate Injection USP products. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Morphine Sulfate Injection USP products to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Morphine Sulfate Injection USP products will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Morphine Sulfate Injection USP products could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; uncertainties regarding actual or potential legal proceedings, including, among others, intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling Morphine Sulfate Injection USP products, and the uncertain outcome of any such litigation; the particular prescribing preferences of physicians and patients; competition in general; government, industry and general public pricing pressures; unexpected manufacturing difficulties or delays; unexpected product manufacturing issues, including the potential outcome of the Warning Letter issued to three Sandoz manufacturing facilities; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Sandoz Canada is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sandoz Canada Inc.
Established in Boucherville, Quebec, Sandoz Canada is part of Sandoz International GmbH, the world's second largest producer of generic drugs and a subsidiary of the Swiss multinational corporation, Novartis.  A leader in its field, Sandoz Canada develops, produces, markets and distributes a wide range of generic products used, among others, in anaesthesia, infectious diseases, oncology, cardiology, and pain management. The Boucherville manufacturing plant specializes in the production of key injectable products.

Marija Mandic
Sandoz Global Media Relations
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