April 2012 Drug Information Update - Pharmacy Benefits ...

2 mL vial, preservative-free (NDC 66758-0040-02)
10 mL vial, preservative-free (NDC 66758-0040-08)
40 mL vial, preservative-free (NDC 66758-0041-01)
Reason for the Shortage
• APP has discontinued their methotrexate 25 mg/mL (with preservative) 2 mL vials. The 10 mL
vials are on shortage due to increased demand for the product. FDA approved preservative-free
methotrexate from APP in February, 2012.
• Ben Venue voluntarily suspended all manufacturing and distribution in mid-November, 2011 on a
temporary basis for maintenance and requalification of equipment. Product will become available
in stages as production resumes.
• Bedford Laboratories has temporarily suspended the distribution of Ben Venue Laboratories
manufactured products. Availability of products is updated on the Bedford Laboratories website.
• Hospira has methotrexate on shortage due to manufacturing delays.
• Sandoz recalled their 2 mL and 10 mL methotrexate preservative-free vials in October, 2010.
Sandoz cannot provide a reason for the current shortage.
• Mylan Institutional (formerly Bioniche) cannot provide a reason for the shortage.
• Bioniche was acquired by Mylan Institutional in September, 2011.
Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=26
Source: www.ashp.org
Azathioprine Injection
March 26, 2012
Products Affected - Description
Azathioprine injection, lyophilized powder, Bedford
100 mg vial (NDC 55390-0600-20)
Reason for the Shortage
• Ben Venue voluntarily suspended all manufacturing and distribution in mid-November, 2011 on a
temporary basis for maintenance and requalification of equipment. Product will become available
in stages as production resumes.
• Bedford Laboratories has multiple products affected by this temporary suspension of
manufacturing. Bedford will have the affected, as well as the available products, listed on their
website and are updating this information as it changes.
• There are no other manufacturers of azathioprine injection.
• The oral presentations are not affected by this shortage.
Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=794
Source: www.ashp.org
Protamine Sulfate
March 27, 2012
Products Affected - Description
Protamine Sulfate 10 mg/mL, American Pharmaceutical Partners (APP)
5 mL vials (NDC 63323-0229-05)
5 mL Novaplus vials (NDC 63323-0229-15)
25 mL vials (NDC 63323-0229-30)
25 mL Novaplus vials (NDC 63323-0229-35)
Reason for the Shortage
APP has protamine on shortage due to increased demand.
There are no other manufacturers of protamine sulfate.
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