LAWSUITS NEWS & LEGAL INFORMATION
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.
Published on Oct-28-10
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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If you or a loved one has suffered an adverse health event from exposure to this product, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.Published on Oct-28-10
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READER COMMENTS
Tina Townsley
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Cause of death - Methotrexate toxicity Bone marrow
This was in 2005. She felt great, she had just stated taking it and boom - never spoke to me again after she was admitted to the ICU.
Her kidneys failed as well.
I had no idea the dangers of the drug and I am sure she was not ready to pass at age 64. She was enjoying her grand son way too much!
Reading these stories makes me sick. I should have followed up with cause of death.
Thanks for listening.
Tina
mike cheatwood
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Harold Bates Sr
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Katherine Norman
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Lori
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Jessica Hitch
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Diane
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Andie Savastano
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Brian Maguire
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Francis burns
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christie rask
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I tend to react to meds fairly fast.
Mark Teske
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Ashley Maracle
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Gladys Catlin
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rosemarie morris
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Cassie
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Oddessa Johnson
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kimberly kaiser
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Krista Cormier
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This past month he deteriorated and fell last week. He had 2 blood clots in his leg, which went dead, requiring emergency surgery. The surgery advanced his cirrhosis and he died last night at age 76. Please get this drug off the market!!!
Mary Muscarello
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This is a horrible medicine that has taken away my dad, a husband and a caretaker. I want something done to prevent further destruction to other families
Please give me information on how we can also get on a class cation Lawsuit case
Lori S Campbell
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I am searching for Class Action to participate in.
Thank you in advance for any information you may offer.
Erin
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My husband was on it for around 2 years and now suffers from pulmonary fibrosis.
The specialist says it's RA induced, but he had NO lung problems before taking this medicine.
He now is on oxygen and has not been given much hope.
Thank you for your time given,
Erin
Lisa
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Beverly Disney
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Johnna Weaver
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Mike
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Melissa andrews
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Luther Elrod
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Bettie Willians
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