Methotrexate 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):
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):
If you are prescribed Methotrexate, please verify that your medication is not from the recalled 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 firstname.lastname@example.org, 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