From:
Sukie Crandall
Date: 2010-09-25 01:35:41 UTC
Subject: [ferrethealth] a recall of some vials of Epogen and Procrit
To: fhl <ferrethealth@yahoogroups.com>
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMe=
dicalProducts/ucm227225.htm
> Epogen and Procrit (epoetin alfa): Recall - Particulate Matter in=20
> Vials
[This medication is used for ferrets, too.]
> [Posted 09/24/2010]
>
> AUDIENCE: Risk Manager, Oncology, Nephrology
>
> ISSUE: Amgen and FDA notified healthcare professionals that certain=20
> lots of Epogen and Procrit (Epoetin alfa) vials are being recalled=20
> as a precaution, because the vials may contain extremely thin glass=20
> flakes (lamellae) that are barely visible. The potential serious=20
> adverse events resulting from the use of a sterile injectable=20
> product with particulates by the intravenous route include embolic,=20
> thrombotic and other vascular events (e.g., phlebitis), and by the=20
> subcutaneous route include foreign body granuloma, local injection=20
> site reactions, and increased immunogenicity.
>
> BACKGROUND: The products are indicated for the treatment of anemia=20
> related to HIV therapy, chronic renal failure, and chemotherapy. The=20
> lamellae result from the interaction of the formulation with glass=20
> vials over the shelf life of the product. The affected product lot=20
> numbers and expiration dates are included in the table in the firm=20
> press release, linked below.
>
> RECOMMENDATIONS: Amgen has initiated recall letters which include=20
> instructions to return the referenced product to the returned goods=20
> service provider.
>
> Healthcare professionals and patients are encouraged to report=20
> adverse events or side effects related to the use of these products=20
> to 1-800-77-AMGEN or to the FDA's MedWatch Safety Information and=20
> Adverse Event Reporting Program:
>
> =95 Complete and submit the report Online: www.fda.gov/MedWatch/report.h=
tm
> =95 Download form or call 1-800-332-1088 to request a reporting form, =
> then complete and return to the address on the pre-addressed form,=20
> or submit by fax to 1-800-FDA-0178
>
> [09/24/2010 - Press Release - FDA]
>
To find the lot information scroll down in
http://www.fda.gov/Safety/Recalls/ucm227202.htm
Sukie (not a vet)
Recommended ferret health links:
http://pets.groups.yahoo.com/group/ferrethealth/
http://ferrethealth.org/archive/
http://www.afip.org/ferrets/index.html
http://www.miamiferret.org/
http://www.ferrethealth.msu.edu/
http://www.ferretcongress.org/
http://www.trifl.org/index.shtml
http://homepage.mac.com/sukie/sukiesferretlinks.html
all ferret topics:
http://listserv.ferretmailinglist.org/archives/ferret-search.html
"All hail the procrastinators for they shall rule the world tomorrow."
(2010, Steve Crandall)
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