Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA
FDA recall notice · announced January 29, 2014 · Cubist Pharmaceuticals
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The product
Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA
Reason for recall
Presence of Particulate Matter; Glass particulates observed in vials
Notes
Distribution: Nationwide
Lot/code information: Lot Numbers: Lot 950453F, Exp. 12/06/2013 Lot 090203F, Exp. 09/07/2014 Lot 201703F, Exp. 08/31/2015 Lot 201653F, Exp. 09/01/2015
Quantity: 179,870 vials
Status: Terminated
Products in this recall event:
- Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA (D-764-2014)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.