The FDA has issued a safety alert for some vials of methotrexate, which may contain small flakes of glass. Sandoz is recalling the following products:
Product : Methotrexate Injection, USP, 50mg/2mL
NDC Number : 66758-040-02 (10 vial pack) and 66758-040-01 (Individual vial)
|
Lot Number
|
Label Type
|
Exp Date
|
|---|---|---|
| 92395606 | Parenta | 12/2010 |
| 92760803 | Parenta | 2/2011 |
| 92965104 | Parenta | 3/2011 |
| 92965106 | Parenta | 3/2011 |
| 92965904 | Parenta | 4/2011 |
| 93255704 | Parenta | 6/2011 |
| 93502204 | Parenta | 7/2011 |
| 93635404 | Parenta | 8/2011 |
| 93681704 | Parenta | 8/2011 |
| 93794904 | Sandoz | 9/2011 |
| 95198604 | Sandoz | 10/2011 |
| 95357804 | Sandoz | 12/2011 |
| 95537704 | Sandoz | 1/2012 |
| 95987004 | Sandoz | 3/2012 |
Product : Methotrexate Injection, USP, 250mg/10mL
NDC Number : 66758-040-08 (10 vial pack) and 66758-040-07 (Individual vial)
|
Lot Number
|
Label Type
|
Exp Date
|
|---|---|---|
| 92395703 | Parenta | 12/2010 |
| 92760903 | Parenta | 2/2011 |
| 92965203 | Parenta | 3/2011 |
| 92966003 | Parenta | 4/2011 |
| 93255803 | Parenta | 6/2011 |
| 93502303 | Parenta | 7/2011 |
| 93635503 | Parenta | 8/2011 |
| 93795003 | Sandoz | 9/2011 |
| 95198703 | Sandoz | 10/2011 |
| 95357903 | Sandoz | 12/2011 |
If you have one of the affected vials, call the dedicated Methotrexate Recall Hotline at 1-888-896-4565 (staffed around the clock) or email Sandoz.methotrexaterecall@gencopharma.com. If you have already used some of the methotrexate and have experienced any side effects that you think might be related to the recall, contact your doctor right away.
I never had any side effect, I never vomited either when I took the pills. I was switched to injectable Methotrexate on Nov.30 of last year, so I give myself a weekly injection. I already consult with my doctor referring The FDA new safety alert, and he said it’s not nothing I personally should worried about. I just wanted to report that here as regular reader of this category.
Bless You
Sam