Sandoz Inc. just initiated a voluntary recall in the United States of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand <"http://www.yourlawyer.com/practice_areas/defective_drugs">Methotrexate Injection, USP product (â€œmethotrexateâ€) to the consumer/user level, the US Food and Drug Administration (FDA) just announced.
Sandoz stated that it is initiating this voluntary recall of all 24 lots of the affected product after finding 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.
Due to particle size, there is the potential to develop adverse reactions in areas in which the particles lodge. While it is unlikely, parenteral injection of drug from the affected lots could lead to serious adverse events, resulting in disability and death.
Additionally, neurologic damage could result from intrathecal administration. Potential adverse events after intravenous administration include local damage to blood vessels in the lung, localized swelling, and granuloma formation. Intramuscular administration could result in foreign-body inflammatory response, with local pain, swelling, and possible long-term granuloma formation. Intra-arterial administration could result in damage to blood vessels in the distal extremities or organs.
To date, Sandoz has not received any adverse event reports or product complaints linked to particles from any methotrexate lot, including lots where flakes were found.
Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis.
The affected products are only the 50mg/2mL and 250mg/10mL presentations of methotrexate. The product lot numbers, label type, and expiration dates can be found on the FDA website at: http://www.fda.gov/Safety/Recalls/ucm231430.htm
as well as on the Sandoz US website at www.us.sandoz.com. Detailed, important safety information is also provided on the FDAâ€™s website. Sandoz has sent out recall letters to inform all distributors, wholesalers, and pharmacies of the voluntary recall, which is being conducted with the knowledge of the 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. As noted on the productâ€™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 FDAâ€™s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax: Online:www.fda.gov/medwatch/report.htm; Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; Fax: 1-800-FDA-0178
Customers and patients can arrange for return and reimbursement through GENCO Pharmaceutical Services, the returns vendor for Sandoz, by calling the dedicated Methotrexate Recall Hotline of 1-888-896-4565 or by sending a message to the dedicated Methotrexate Recall Email at Sandoz.email@example.com. Operators are available 24 hours a day, seven days each week.