Important Drug Warning: Counterfeiting of Procrit

• Original Letter (June 6, 2002)
• Additional Counterfeit Lot (June 7, 2002)

This is the re-typed text of a letter from Ortho Biotech Products, L.P. . Contact the company for a copy of any referenced enclosures.

Original Letter

Dear Health Care Professional:

Ortho Biotech Products, L.P. (OBPLP) recently became aware of the existence of counterfeit drug product labeled as PROCRIT® (epoetin alfa)* 40,000 U/mL vials in four-pack boxes, lot number P002641 and expiration September 2003. OBPLP is informing physicians, pharmacies, and wholesalers/distributors about this potentially serious health risk. PROCRIT is used primarily for the treatment of anemia associated with chemotherapy, chronic renal failure (pre-dialysis), zidovudine treatment in HIV patients, and patients undergoing elective, noncardiac, nonvascular surgery.

Based upon the evidence we have reviewed to date, we have determined that these vials are indeed counterfeit. Analysis shows that they contain a clear liquid with active ingredient. The examined vials appear to be intact. However, the concentration of active ingredient is approximately 20 times lower than expected for PROCRIT 40,000 U/mL vials. Based upon evidence available to date, it appears that counterfeiters may be acquiring PROCRIT 2,000 U/mL vials and relabeling the product with counterfeit 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.

Authentic PROCRIT, lot number P002641, expiration September 2003 was last shipped from the OBPLP Distribution Center on February 20, 2002. Based on historical usage patterns and inventory practices, it is likely that virtually all authentic PROCRIT with lot number P002641, already has been used. Thus, any product bearing this lot number in particular, should be considered suspect and be closely examined.

Physicians, pharmacists, nurses and all other healthcare professionals should carefully examine all PROCRIT vials before use. The following information may help in determining if the product you have is counterfeit.

This counterfeit product deviates from authentic PROCRIT in that the counterfeit product may:

• Have a visible "strike-through" on number 6 in the lot number on the vial.
• Have text alignment on the bottom of the folding carton (box) that is shifted to the extreme right side of the panel.
• Have a varnished (shine/gloss) fluted tray, which holds the vials in place. The authentic product has an unvarnished fluted tray that has no shine/gloss.

In order to view pictures illustrating these differences, please log onto www.procrit.com or www.orthobiotech.com.

Features of Authentic Epogen	Features of Counterfeit Product
VIAL: No "strike-through" on number "6" as it appears in the lot number. Photo #1	VIAL: "Strike through" on number "6" as it appears in the lot number. Photo #2
FOLDING CARTON (BOX): Text alignment on bottom of folding carton appears with a right hand margin between end of text and edge of carton. Photo #3	FOLDING CARTON (BOX): Text alignment on bottom of folding carton may be shifted to extreme right side of panel without a right hand margin. Photo #3

Please convey this information to your staff and any others who administer PROCRIT so that they will be able to identify the characteristics of a suspect counterfeit vial.

If you receive any product that you suspect is counterfeit, do not use the product. Please quarantine and store the product under labeled conditions. Promptly contact the FDA at 1 (800) 835-4709, prompt #5 for further instructions. If you suspect that you may be in possession of counterfeit PROCRIT, you should immediately contact your wholesaler/supplier regarding refund for the product.

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

OBPLP is cooperating fully with the FDA to investigate this matter and prevent the further distribution of counterfeit product. As of June 6, 2002, OBPLP is aware of the distribution of counterfeit product in the U.S. only.

Full product information and updates on this situation will be available at www.procrit.com or www.orthobiotech.com. For those who do not have Internet access, please contact Ortho Biotech Medical Information at 1 800 325-7504, prompt #2

Martine George, M.D.
Vice President
Clinical Affairs - North America, Ortho Biotech Products, L.P.

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

Other Contact Information

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

*PROCRIT is the brand name of epoetin alfa manufactured by Amgen Inc., and marketed by Ortho Biotech Products, L.P.

Additional Counterfeit Lot

Ortho Biotech Products, L.P. is updating its information to physicians, pharmacies and wholesalers/distributors to report additional counterfeit PROCRIT (Epoetin alfa). In addition to lot number P002641, discussed in the notice below dated June 6, 2002, the following lot number has also been determined to be counterfeit product.

PROCRIT® 40,000 U/mL
Lot Number: P002384
Expiration: 03/2003

Authentic PROCRIT, lot number P002384 with expiration date March 2003, was last shipped from the OBPLP distribution center on September 4, 2001. Based on historical usage patterns and inventory practices, it is likely that virtually all authentic PROCRIT with lot number P002384, already has been used. Distinctions between this counterfeit lot and authentic PROCRIT are still being analyzed.

Distinctions may not be the same as those identified in the Dear Healthcare Professional letter dated June 6, 2002. Thus, any product bearing this lot number in particular should be considered suspect. 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 quarantine and store the product under labeled conditions. Promptly contact the FDA at 1 (800) 835-4709, prompt #1, and then prompt #5 for further instructions. If you suspect that you may be in possession of counterfeit product labeled as PROCRIT, you should immediately contact your wholesaler/supplier regarding refund of the product.

Further updates will be posted on www.procrit.com and the United States link on www.orthobiotech.com as soon as new information becomes available.