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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

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.
Recall Number D-1382-2014
Classification Class I
Code Info Lot #: 280453F, Exp 04/16
Product Distributed Qty 51,500 vials
Reason For Recall Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.

Event Detail

Event Id 68025
Product Type Drugs
Status Ongoing
Recalling Firm Cubist Pharmaceuticals, Inc.
City Lexington
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico.