Amgen - Patients - Products - Counterfeit Warning

Important Drug Warning - Counterfeiting of NEUPOGEN®

Updated Information
June 21, 2001 Newly identified counterfeit lot P000954, Expiration: 05/03
June 6, 2001 Additional confirmed and suspected counterfeit lots

May 10, 2001

Dear Health Care Professional:

Amgen Inc. recently became aware of the existence in the U.S. of a counterfeit drug product labeled as NEUPOGEN® 300 mcg vials in ten-pack boxes. In cooperation with the U.S. Food and Drug Administration (FDA), Amgen is informing patients, physicians, pharmacies, and wholesalers about this serious health risk.

The counterfeit vials examined to date contain a clear liquid but no active ingredient.

The counterfeit product, which is definitely not NEUPOGEN (Filgrastim), was neither manufactured nor distributed by Amgen and may pose a serious health risk to patients.

The following information may help in determining if the product you have is counterfeit or actual NEUPOGEN manufactured and distributed by Amgen. Pharmacists and all other health care providers should examine the product before use.

Features of counterfeit product	Features of authentic NEUPOGEN
Lot number P000948	No such NEUPOGEN lot number exists
Lot number P000890 and expiration 12/02	Lot number P000890 and expiration 02/02
Underside of vial stopper indented Photo	Underside of vial stopper flat
Vial height is approximately 35 mm Photo	Vial height is approximately 34 mm
Patient insert: Is on regular stock paper Has no boxes around drawings Printing on back page is inverted Photo	Patient insert: Is on thin, light-weight, pale blue paper Has boxes around drawings Same orientation printing on front and back
Physician insert: Is on regular stock paper Dimensions are too small, unfolded Photo	Physician insert: Is on thin, light-weight paper Dimensions are 16"x24", unfolded
Underside of flip-top has 6 dents on metal edge Photo	Underside of flip-top has smooth, even metal edge
Top surface of stopper has a raised round ridge Photo	Top surface of stopper is indented
Label font for product name and concentration is rounder Photo	Label font for product name and concentration is narrower
Font used for lot number and exp on carton is narrower Photo	Font used for lot number and exp on carton is rounder
Brand name on box is lighter, not as bold Photo	Brand name on box is darker and bolder
Poor print quality on label and box Photo	Crisp, high-quality print on label and box

Updated Information: June 21, 2001
The following additional lot number has been confirmed as counterfeit.
Features of counterfeit product	Features of authentic NEUPOGEN
Lot number P000954 Expiration 05/03	No such NEUPOGEN lot number exists

Updated Information: June 6, 2001
The following additional lot number has been confirmed as counterfeit.
Features of counterfeit product	Features of authentic NEUPOGEN
Lot number P000992 Expiration 06/03	Lot number P000992 Expiration 06/02
The following additional lot numbers are suspected, but not confirmed to be, counterfeit.
Features of suspected counterfeit product:	Features of authentic NEUPOGEN:
Lot Number P000905 Expiration 08/02	Lot Number P000905 Expiration 02/02
Lot Number P000889	No such NEUPOGEN lot number exists
Lot Number P000819	No such NEUPOGEN lot number exists

If you receive any product that you suspect is counterfeit, please refer to the images of counterfeit product below, quarantine it and store it under labeled conditions. Please contact the FDA promptly at 1-800-835-4709. If you have questions about NEUPOGEN, please contact Amgen Professional Services at 1-800-772-6436. Please convey this information to your staff and any others who administer NEUPOGEN. You should instruct them on what to look for and what to do in the event they find a suspect counterfeit vial.

Amgen is cooperating fully with the FDA to investigate this matter and prevent the further distribution of counterfeit product. To Amgen's knowledge, the counterfeit product has only been found in distribution in the U.S.

NEUPOGEN is primarily used to prevent infection, as manifested by febrile neutropenia in cancer patients receiving myelotoxic chemotherapy. Full product information and any updates on this situation are available at http://www.neupogen.com/.

Other Contact Information:
U.S. Food and Drug Administration (for press inquiries): 301-827-6242

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