FOR IMMEDIATE RELEASE – October 27, 2010 – Sandoz Inc. announced today it has initiated a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product (“methotrexate”) to the consumer/user level. Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots. The flakes are the result of delamination of the glass used to manufacture the vials of these two dosage presentations.
Product : Methotrexate Injection, USP, 250mg/10mL
NDC Number : 66758-040-08 (10 vial pack) and 66758-040-07 (Individual vial)
Sandoz has sent out recall letters to inform all distributors, wholesalers and pharmacies of the voluntary recall. The recall is being conducted with the knowledge of the United States Food and Drug Administration (FDA).
Customers and patients should immediately discontinue use of this product and patients should contact their physician or healthcare provider if they experience any problem that might be related to the use of this product. Additionally, as noted in the product’s labeling, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Adverse events related to the use of Sandoz methotrexate product should be reported to Sandoz at 1-800-525-8747 or to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
DISCLAIMER The foregoing release contains forward-looking statements that can be identified by terminology such as “may,” “potential,” “could,” or similar expressions, or by express or implied discussions regarding the recall of methotrexate injection, or regarding potential future revenues from methotrexate injection. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management’s expectations 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, product liability litigation, government investigations and intellectual property disputes; competition in general; government, industry and general public pricing pressures; unexpected patent litigation outcomes; unexpected issues in remedying the metotrexate injection manufacturing process; 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. Novartis 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.