Sandoz Recalls in the US of all Vials of Methotrexate Injection–Glass Flakes in the Drug- Deaf FDA & Drug Company Ears As
Posted Oct 29 2010 6:30pm
Well my campaign for 2D bar coding is still alive and well but the FDA and the drug and device companies still seem pretty deaf. The drug injection are used to treat severe psoriasis, and rheumatoid arthritis and a few other conditions. I started campaign about a year ago and it has a permanent spot on the Medical Quack as it is the right thing to do with the right technology. We can shop and do all kinds of other things here but we can’t get into saving lives it seems.
We just love as citizens to have to take time and dig through all this stuff that is surmounting every week. I even wrote to the FDA a couple times but no answer so no enthusiasm or comments, so that’s what we have here. Private industry already has produced over 2 billion bar code tags so again we have some real deaf ears and perhaps some 70s folks still hanging on.
A couple drug companies are looking at it though they have told me, which is great but it will need collaboration as well as innovation to get this moving but think of the value for the consumer, doctors, hospitals and anyone else. Just picture below a bottle or box of drugs or a medical devices that could be scanned this way to find out if the product has been recalled and too whether or not it is legit. One technology that does a lot.
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. Due to particle size, there is the potential to develop adverse reactions in areas where 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 attributable to particles from any lot of methotrexate, including the lots where flakes have been 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 are listed below as well as on the Sandoz US website at www.us.sandoz.com.