Methotrexate medication recalled by manufacturer

FDAMethotrexate is an immunosuppressant medication sometimes used in the treatment of Inflammatory Bowel Disease. 1http://www.med.unc.edu/gi/specialties/ibd/images/treatment-of-crohns/Methotrexate.pdf 2http://www.nlm.nih.gov/medlineplus/druginfo/meds/a682019.html  On April 23, 2015, Mylan N.V. pharmaceuticals, voluntarily recalled lot #7801082 of its Methotrexate product “due to the presence of visible foreign particulate matter observed during testing of retention samples”.3http://www.fda.gov/Safety/Recalls/ucm444498.htm

 

According to the FDA’s press release:

The lot was distributed in the U.S. between Jan. 16, 2014, and March 25, 2014, and was packaged by Agila Onco Therapies Limited, a Mylan company, with a Pfizer Injectables label. 4http://www.fda.gov/Safety/Recalls/ucm444498.htm

 

Here are the full details on the particular lot that is being recalled 5http://www.fda.gov/Safety/Recalls/ucm444498.htm:

 

NDC # Product Name & Strength Size Lot Number Expiration Date
0069-0146-02 Methotrexate Injection, USP 25mg/mL 2 mL (5 x 2 mL) 7801082 07/2015

 

According to the information provided by Mylan 6http://www.mylan.com/news/press-releases/item?id=123302 and the FDA 7http://www.fda.gov/Safety/Recalls/ucm444498.htm, medication from the recalled lot likely came in a carton of 5 individually boxed vials. Each individual vial contains 2 mL at 50 mg/2 mL (25mg/mL). While the medication is manufactured by Mylan, the labeling on the boxes will most likely say “Pfizer Injectables”.

 

Based on the NDC (National Drug Code) number of the recalled lot, here is an example of what one of the individual boxes may look like (Please note, your labels may look different. Check your lot number and call your doctor/pharmacist if unsure):

 

Methotrexate box

Pfizer Injectables Methotrexate box 8http://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5c960719-19a3-442d-a24b-189b4760ab69&type=display

 

Based on the NDC (National Drug Code) number of the recalled lot, here is an example of what the label on each individual vial may look like (Please note, your labels may look different. Check your lot number and call your doctor/pharmacist if unsure):

 

Pfizer injectables label

Pfizer Injectables Methotrexate label 9http://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5c960719-19a3-442d-a24b-189b4760ab69&type=display

 

If you are prescribed Methotrexate, please verify that your medication is not from the recalled lot – #7801082.

 

Check here

Check here for Lot #7801082

 

If your Methotrexate is from Lot #7801082, do not take it. Call your doctor and let them know you have a medication that has been recalled.

If you have any questions or concerns regarding this, it would be best to speak with your doctor or pharmacist. You may also contact Mylan Customer Relations (information listed below).

 

Here is the official FDA report on Mylan’s recall: http://www.fda.gov/Safety/Recalls/ucm444498.htm

Here is the press release on Mylan’s website: http://www.mylan.com/news/press-releases/item?id=123302

Consumers with questions regarding this recall can contact Mylan Customer Relations at 800.796.9526 or customer.service@mylan.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products. 10http://www.fda.gov/Safety/Recalls/ucm444498.htm

 

 

References   [ + ]

1. http://www.med.unc.edu/gi/specialties/ibd/images/treatment-of-crohns/Methotrexate.pdf
2. http://www.nlm.nih.gov/medlineplus/druginfo/meds/a682019.html
3, 4, 5, 7, 10. http://www.fda.gov/Safety/Recalls/ucm444498.htm
6. http://www.mylan.com/news/press-releases/item?id=123302
8, 9. http://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5c960719-19a3-442d-a24b-189b4760ab69&type=display
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