MedWatch - Procrit counterfeit UPDATE

The FDA Safety Information and Adverse Event Reporting Program

2002 Safety Alert - Procrit (Epoetin alfa)

This is the text of a letter from Ortho Biotech. Contact the company for a copy of any referenced enclosures.

October 11, 2002

Additional Counterfeit Product Labeled as PROCRIT (Epoetin alfa)
Bearing Lot Number P004582.

In a further update to the June 6, 2002 letter to healthcare professionals, additional counterfeit product labeled as PROCRIT has been found bearing lot number P004582, expiration 02/2004. To date, three lot numbers have been identified that may contain counterfeit product labeled as PROCRIT:

PROCRITŽ 40,000 U/mL

Lot Number: P004582

Expiration: 02/2004

Date of Last Shipment from Ortho Biotech: 07/01/02

Lot Number: P002384

Expiration: 03/2003

Date or Last Shipment from Ortho Biotech: 09/04/01

Lot Number: P002641

Expiration: 09/2003

Date of Last Shipment from Ortho Biotech: 02/20/02

Authentic PROCRIT, lot number P004582 with expiration date February 2004, was last shipped from the Ortho Biotech distribution center on July 1, 2002. Based on historical usage patterns and inventory practices, it is likely that virtually all authentic PROCRIT with lot number P004582, has already been used. Any product bearing this lot number should be considered suspect.

Analyses of counterfeit product labeled as PROCRIT indicate that these vials contain a clear liquid with active ingredient. The examined vials appear to be intact. Counterfeiters may be acquiring PROCRIT 2,000 U/mL vials and re-labeling the product with counterfeit PROCRIT 40,000 U/mL labels. Because of the lower than labeled strength of the counterfeit vials, it is possible that patients could be under-dosed. In addition, other potential health risks cannot be ruled out at this time.

Physicians, pharmacists, nurses and all other healthcare professionals should carefully examine all PROCRIT packaging and vials before use. If you receive any product that you suspect is counterfeit, do not use the product. Please store the product under labeled conditions. Promptly contact the FDA at 1 (800) 835-4709, press prompt #1, followed by prompt #5 for further instructions.

Beginning July 1, 2002, Ortho Biotech began placing polychromatic (color-shifting) seals on the tuck flaps of all PROCRIT 40,000 U/mL cartons. A letter describing these changes was mailed to healthcare professionals on June 28, 2002. PROCRIT 40,000 U/mL cartons bearing lot numbers P004583, P004677, P004839, P005091, P005264, P005265, P005688 and P005689 received the new seals. Color-shifting seals will be affixed to the packaging of all other strengths of PROCRIT in the coming months.

Ortho Biotech will implement additional changes to the appearance of all PROCRIT packaging. Alterations to the packaging will be made to enhance the tamper-evident appearance of our products. Information related to these changes will be provided in a direct mailing to occur prior to distribution of the first lot bearing these changes.
Previous communications on this topic, full product information, and updates on this situation may be found at http://www.procrit.com/ and the United States link on http://www.orthobiotech.com/.

If you have medical questions regarding suspected product labeled as PROCRIT, please contact Ortho Biotech Medical Information at 1 (800) 325-7504, prompt #2.

OBPLP is committed to supporting the patients and healthcare professionals who rely on our products. We thank you for your cooperation in this serious matter.

Counterfeit product labeled as PROCRIT with lot number P004582, expiration February 2004 deviates from authentic PROCRIT in that the counterfeit product may have one or more of the following characteristics:

Features of Authentic
Product Labeled as
PROCRIT 40,000 U/mL
with LOT P004582,
EXP 02/2004

Features of Counterfeit Product Labeled as
PROCRIT 40,000 U/mL
with LOT P004582,
EXP 02/2004

FOLDING CARTON (BOX): On the left panel of the box, the number “40” does not wrap around the right corner of the panel. There is a space between the number “40” and the edge of the box.

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FOLDING CARTON (BOX): On the left panel of the box, the number “40” wraps around the right corner of the panel. There is no space between the number “40” and the edge of the box.

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FOLDING CARTON (BOX):On the bottom panel of the box, there is no smudge or black dot above the “b” in the word Albumin.

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FOLDING CARTON (BOX): On the bottom panel of the box, there is a smudge or black dot above the letter “b” in the word Albumin.

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VIAL: There are no imperfections found on the edges of the label.

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VIAL: A notch may appear in the black colored bottom edge of the label under the words “LOT” and “EXP”.

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