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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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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
Distribution Pattern Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot #: 1037592, Exp 07/15 Class II Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination. 4,163 prefilled syringes D-66318-001