September 2013 FDA Recall Prolia by Amgen, Inc.
D-66318-001 - Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by Amgen, Inc. on September 17, 2013 for the product Prolia. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-66318-001

Reason for Recall
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Initiated
09-17-2013
Reported
11-13-2013
Quantity
4,163 prefilled syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66318
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amgen, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-02-2014
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# : 1037592, Exp 07/15

Affected Packages Involved in this Recall

55513-710-01 Prolia
55513-710-21 Prolia