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Sandoz Recalls Methotrexate

Washington, DC: Sandoz Inc. announced today it has initiated a 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.

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. For a complete list of affected product lot numbers, label type and expiration dates see the link below.

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Last updated on Oct-28-10


Posted by
Bettie Willians
I was seeing a MD I had one ace on my right shin ask him about it he said it look like skin cancer. He got an appointment with Dr N. Went in he gave me a shot that made the place puff up then he drew out some fluid went to lab came back and said at least it is not melanoma He put me on Methotrexate 2.5 once a week. I took this along with other meds:naproxen500mg 2a day Hydrochlothiazide25mg 1a day Gabapentin 600mg 3a day. I lost my strength I could not walk I lost my memory I am slowly remembering and walking slowly these meds caused my face to swell and my eyes were shut the left side was so hot it blistered I was taken to urgent care by my husband I don't remember this trip. I am still affected on both legs and feet top and bottom I hope you can help me.


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