Drug product
CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.
D-1382-2014
Product summary
- Event
- Event 68025
- Status
- Terminated
- Classification
- Class I
- Quantity
- 51,500 vials
- Official record key
drug-enforcement:D-1382-2014
Official wording
Reason: Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
Code information: Lot #: 280453F, Exp 04/16
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter