Hospira and the FDA are notifying healthcare professionals of a nationwide recall of 19 lots of injectable carboplatin, cytarabine, paclitaxel, and methotrexate due to visible particles embedded in the glass at the neck of the vial.
The affected products contain the following lot and batch numbers (distributed from September 2011–April 2012):
- Carboplatin Injection 450mg/45mL, 10mg/mL, 45mL multi-dose vial: Lot# 003390450 (Y061711AA, Y061711AB)
- Cytarabine Injection 1000mg/50mL, 20mg/mL, 50mL vial: Lot# 003030446 (Y131994AA, Y141994AA, Y151994AA, Y161994AA, Y171994AA, Y181994AA)
- Paclitaxel Injection 300mg/50mL, 6mg/mL, 50mL multi-dose vial: Lot#003420450 (Y096865AA, Y106865AA, Y116865AA, Y126865AA, Y136865AA, Y146865AA, Y156865AA, Y166865AA, Y176865AA, Y186865AA)
- Methotrexate Injection 1g/40mL, 25mg/mL, 40mL vial: Lot#004080441 (Y064457AA)
There may be potential for the product to come into contact with the embedded particles which may become dislodged into the solution. Adverse events include bleeding, bruising, inflammation, itching, rash, chest pain and respiratory symptoms. Anyone with an existing inventory is recommended to call Stericycle at (888) 628-0734 to arrange for the return of the product.
Carboplatin, cytarabine, paclitaxel, and methotrexate are used to treat various types of cancer. In addition, methotrexate is also used to treat psoriasis and rheumatoid arthritis.
For more information call (877) 946-774 or visit http://www.fda.gov/Safety/Recalls/ucm311971.htm.