Drug product
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
Product summary
- Event
- Event 66041
- Status
- Terminated
- Classification
- Class I
- Quantity
- 179,870 vials
- Official record key
drug-enforcement:D-764-2014
Official wording
Reason: Presence of Particulate Matter; Glass particulates observed in vials
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
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter