April 2012 Drug Information Update - Pharmacy Benefits ...

Cytarabine Injection
March 20, 2012
Products Affected - Description
Cytarabine injection (powder for reconstitution), Bedford
100 mg vial (NDC 55390-0131-10)
500 mg vials (NDC 55390-0132-10)
1 gram vials (NDC 55390-0133-01)
100 mg (Novaplus) vial (NDC 55390-0806-10)
500 mg (Novaplus) vials (NDC 55390-0807-10)
1 gram (Novaplus) vials (NDC 55390-0808-01)
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 temporarily suspended the distribution of Ben Venue Laboratories
manufactured products. Availability of products is updated on the Bedford Laboratories website.
• Bedford issued a voluntary recall of 3 lots of cytarabine 1 gram vials in February, 2012. The
company determined there was a potential increased risk for lack of sterility with these specific
lots. More information can be found online.
• Bedford states the cytarabine shortage is due to manufacturing delays. Bedford discontinued
cytarabine 2 gram presentations in May, 2011 to concentrate on the manufacturing of other
products.
• Hospira had found crystallization in some cytarabine 2 gram lots. The company is recommending
to not use product that has crystallization.
• APP recalled one lot of cytarabine in February, 2011 due to potential crystallization or
precipitation in vials.
Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=413
Source: www.ashp.org
Cyclosporine Injection
March 20, 2012
Products Affected - Description
Cyclosporine 50 mg/mL solution for injection, Bedford
5 mL vial, 10 count (NDC 55390-0122-10)
Cyclosporine 50 mg/mL solution for injection, Perrigo
5 mL ampule, 10 count (NDC 00574-0866-10)
5 mL ampule, 10 count (NDC 00574-0866-10) - discontinued
Reason for the Shortage
• Perrigo acquired Paddock Laboratories in July 2011. Perrigo discontinued cyclosporine injection
in late-November, 2011.
• Ben Venue voluntarily suspended all manufacturing and distribution in mid-November, 2011.
Product will become available in stages as production resumes.
• Bedford Laboratories has multiple products affected by this suspension of manufacturing.
Availability of all products, including those not manufactured at Ben Venue, is updated as
information changes on the Bedford Laboratories website.
Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=832
Source: www.ashp.org
52