Methotrexate Injection Recall Issued by Sandoz and Parenta

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Sandoz Inc. is recalling 24 lots of methotrexate, an antimetabolite used to treat diseases like psoriasis and rheumatoid arthritis, because vials may be contaminated with flakes of glass. The methotrexate injections were sold under the Sandoz and Parenta brands.

The FDA announced the methotrexate injection recall on October 27, after Sandoz quality control found small glass flakes in four lots of the injections. According to Sandoz, the flakes got into the vials due to the delamination process that occurs while the vials are being manufactured.

Injection of the glass flakes could lead to the flakes traveling through blood vessels to organs, causing serious injury or death. Injection into muscles could cause swelling, pain, and long-term granuloma formation. There have been no incidents or injuries reported in connection with the tainted drugs.

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The recall affects 24 lots of Sandoz and Parenta brand Methotrexate Injections in 50mg/2mL and 250mg/10mL vials. The vials were distributed in 10 packs and individual vials. The 50mg/2mL vials have lot numbers of 92395606, 92760803, 92965104, 92965106, 92965904, 93255704, 93502204, 93635404, 93681704, 93794904, 95198604, 95357804, 95537704 and 95987004. The vials have expiration dates ranging from 12/2010 to 3/2012. The 250mg/10mL vials have lot numbers of 92395703, 92760903, 92965203, 92966003, 93255803, 93502303, 93635503, 93795003, 95198703 and 95357903. The vials have expiration dates ranging from 12/2010 to 12/2011.

This is at least the third drug recall this year due to glass flake contamination of drug vials. In May, Baxter International, Inc. recalled about 3,200 vials of Hylenex, a pediatric rehydration medication due to glass flakes. In September, about 200 lots of Epogen and Procrit, Amgen’s anemia drugs, were also recalled due to glass flakes. There were no reports of incidents or injuries in either recall.

Sandoz has informed distributors, wholesalers and pharmacies of the recall. The FDA and Sandoz recommend that healthcare professionals and patients immediately discontinue use of this product. Patients should contact their healthcare providers if they experience problems that might be related to contaminated methotrexate injections and should report any adverse events to FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/medwatch/report.htm.

Tags: Arthritis, Drug Recall, Psoriasis
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12 Comments

Sandra
I’m interested in knowing what pharmacy n in what states this medicine was distributed. I have taken methotrexate for a good 7-8 yrs.
cheryl
I took methotextrate for six months at 7 pills weekly (2.5mg or more)… I stopped pills January 2013 after my sister (she’s an LPN) told me it was a harsh drug… now, I have breathing problems and on my second ct scan to ascertain status of lung nodules…Damn, I’m angry w/stupid RA doctor who insisted I take the drug….
allie
cvc still carry it idonot want to take it
Richard
I took Methatrexate for 4!/2 years, only to end up on O2 for the rest of my life. I had a heart attack 1 September 2010. My Dr. told me after puting a stint in the left ventrical that my lungs were badly scared and to stop taking methatrexate. I was also told never to have a General Anthesia because it would kill me. I am 70 yrs old and tired of hauling around oxygen and being limited to it’s activities.
William
I posted back on the 28 of november of 2010 my neck pain(on the side of my neck Both sides) and head ace still are going on with A lot of dizzness and failing down some times.My hands are going to sleep A lot also . I still have not heard nothing about whats going on with this .
Brandi
Methotriaxate is bad news ! I was given this medication when I was pregnant to abort the pregnancy before it killed me . ( Trust me NOT my idea , I was forced to take it , NOT ONCE but TWICE ) . Now I have spots on my lung at the age of 30. EXPLAIN THAT ONE.
Richard
I heard about the recall of methotrexiate from my daughter in law and I took the box of Parenta methotrexiate back to Clinton Pharmacy in Clinton, NJ They told me they knew nothing about any recall, but they took my box of the vials back and it is now a month later and I haven’t heard anything more about it. II have now waited all this time without my medication and I don’t understand why I’m waiting. I thought that I would get a new box to replace the recalled one. I am going to stop using Clinton Pharmacy because I feel they should have informed me of the recall and they should have replaced this medication. Have you heard from them regarding me returning the box to them? I need my medication.
Laura
I have been having bad headaches and even devoped painful lumps on my temple. I’ve been to my doctor, ENT head and neck specialist, rhumatologist, and a neurologist for my pain. I’ve had three catscans-show swelling but no real cause. I know I took the contaminated meds because I still have the vials. All the meds the doctors have tried do not seem to help the headaches. You trust the meds you take will make you feel better, not worse.
William
I receved A letter from C V S stating I have reseved some contamated bottels of Methotrexate.
Julia
METHOTREXATE IS A KILLING MADICATION!! My Mother just Died from this madication!!!!
Ginny
You need to better train your people answering the Recall Hotline. I called last nite and gave the lot # of my 7yr granddaughters medication and I was told that was NOT part of the recall and it is infact part of the recall according to the lot #’s listed above.
KEITH
I TAKE METHOTREXATE AND I WAS HOSPITALIZED A MONTH AGO, MY DOCTORS STOPPED MY TAKING OF IT FOR THE PAST MONTH, I WAS TAKING IT FOR OVER A YEAR AND IT SEEMED TO BE OK, HOWEVER I COULD NOT STOP VOMITING AND WAS HOSPITALIZED. I CHECKED MY VIALS AND INDEED MINE ARE ON THE RECALL LIST, ALL THE NUMBERS MATCHED.

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