FDAFDA · Food and drugs·Recall number D-0229-2015
CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc., Lexington, MA 02421, USA, NDC 67919-011-01
Published November 5, 2014 · Recall initiated: August 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Cubist Pharmaceuticals, Inc.
- Distributor
- Nationwide and Puerto Rico.
- Lot
- Lot #'s: CDC203, Exp 12/2015; CDC207, Exp 01/2016; CDC213, Exp 02/2016; CDC217, Exp 03/2016; CDC226, Exp 04/2016; CDC234, CDC235, Exp 05/2016; CDC243, CDC246, Exp 07/2016.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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