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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA 91320-1799,NDC 55513-710-01, UPC 3 55513 71001 5.
Recall Number D-66318-001
Classification Class II
Code Info Lot #: 1037592, Exp 07/15
Product Distributed Qty 4,163 prefilled syringes
Reason For Recall Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.

Event Detail

Event Id 66318
Product Type Drugs
Status Ongoing
Recalling Firm Amgen, Inc.
City Thousand Oaks
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.