D-1382-2014 Class I Terminated
FDA drug recall D-1382-2014 was initiated by Cubist Pharmaceuticals, Inc. on April 17, 2014 and is designated Class I. Reason for recall: Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard. The recall status is terminated (terminated July 22, 2016). Affected quantity: 51,500 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- June 18, 2014
- Initiation Date
- April 17, 2014
- Termination Date
- July 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51,500 vials
Product Description
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.
Distribution Pattern
Nationwide and Puerto Rico.
Code Information
Lot #: 280453F, Exp 04/16