FDA Recall D-1382-2014
Cubist Pharmaceuticals, Inc. · Lexington, MA
Class I — life-threatening Terminated 827 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Reason for recall
Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
Recall record
- Recall number
D-1382-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide and Puerto Rico.
- Recall initiated
- 2014-04-17
- Classified by FDA Center
- 2014-06-12
- FDA published
- 2014-06-18
- Terminated
- 2016-07-22
- Recalling firm
- Cubist Pharmaceuticals, Inc.
- Firm location
- Lexington, MA