Hospira and Cubist Pharmaceuticals Recall Medications Due to Presence of Particulate Matter

April 30, 2014 4:00 PM Topics: Fda

Hospira, Inc, of Lake Forest, IL, and Cubist Pharmaceuticals, Inc, of Lexington, MA, are voluntarily recalling products due to the presence of particulate matter. The recalled products are:

Cubist Pharmaceuticals

• CUBICIN^® (daptomycin for injection) 500 mg (Lot Number 280453F).

Hospira, Inc

• 0.25% Marcaine^TM (bupivacaine HCI Injection, USP) 10 mL, single-dose vial – Preservative Free (Lot Number 34-440-DD).
• 1% Lidocaine HCI Injection, USP, 10 mg/mL, 30 mL single dose, Preservative Free (Lot Number 31-427-DK).
• Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL). Lot Numbers:
  • 29-614-DJ, 29-615-DJ, 29-616-DJ, 26-617-DJ
  • 29-628-DJ, 29-629-DJ, 29-630-DJ

Depending on size, if undetected, particles could block administration of the drug to a patient, causing a delay in therapy. Other complications could include local inflammation and phlebitis. Health care providers should stop use and distribution, quarantine the products, and follow the instructions in the appropriate recall announcement, available in the Recalls, Market Withdrawals, and Safety Alerts section of FDA’s website. Adverse reactions may be reported to FDA’s MedWatch Adverse Event Reporting Program.

quoted from NABP found here