Four lots of the intravenous antibiotic drug daptomycin (Cubicin) have been recalled because of glass particles found in some vials, the FDA and the drug's manufacturer said.
No injuries have been reported, but the contamination could result in thromboembolism or granulomas, the FDA said.
The affected lot numbers are 950453F, 090203F, 201703F, and 201653F, with expiration dates ranging from Dec. 6, 2013, to Sept. 1, 2015. The lots were shipped from May 2011 to March of this year, according to a statement from manufacturer Cubist Pharmaceuticals posted on the FDA's website.
Cubist said it was notifying customers by telephone and letter. All hospitals and clinics with inventories of daptomycin should check them for vials with the recalled lot numbers and contact the company if any are found. Cubist will arrange for return and replacement of recalled daptomycin vials.
The contamination appeared to originate with a third-party supplier, according to Cubist, which said it had "suspended all manufacturing with the supplier until corrective and preventative measures have been taken."
Label directions for daptomycin specifically call for healthcare providers to check vials for visible particulates before administering the drug to patients, the firm noted. Vials containing particulates should not be used.
http://www.medpagetoday.com/HospitalBasedMedicine/GeneralHospitalPractice/41283
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