Home / Recalls / Amgen, Inc. / D-66318-001

D-66318-001 Class II Terminated

Recalled by Amgen, Inc. — Thousand Oaks, CA

Recall Details

Product Type
Drugs
Report Date
November 13, 2013
Initiation Date
September 17, 2013
Termination Date
June 2, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,163 prefilled syringes

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.

Reason for Recall

Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.

Distribution Pattern

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

Code Information

Lot #: 1037592, Exp 07/15

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