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U.S. Department of Health and Human Services

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Procrit (epoetin alfa) Dear Healthcare Professional Letter Mar 2003

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


 

March 8, 2003

COUNTERFEIT PRODUCT ALERT

Dear Health Care Professional:

This letter is to alert you to a significant new development concerning counterfeit drug. Counterfeit product labeled as PROCRIT®* (Epoetin alfa) 40,000 Units/mL has been found bearing lot numbers P007645, expiration 10/2004; P004677, expiration 02/2004; and P004839, expiration 02/2004.

Testing to date, provided to us by the FDA, indicates that possible contaminants include Acinetobacter and Pseudomonas spp. This counterfeit product appears as a clear liquid (possibly water) with no active ingredient. It is likely that this material was produced under non-sterile conditions. As such, this counterfeit product likely presents a serious health risk to patients. The possibility of other contaminants cannot be ruled out at this time.

While the counterfeit product labeled as PROCRIT bears lot numbers used on authentic PROCRIT packaging and vials, this counterfeit product is not PROCRIT and was neither manufactured for, nor distributed by, Ortho Biotech Products, L.P.

 

Authentic PROCRIT® 40,000 U/mL
Lot number: P007645 Lot number: P004677 Lot number: P004839
Expiration: 10/2004 Expiration: 2/2004 Expiration: 2/2004
Date of last shipment of authentic product from Ortho Biotech: 02/05/2003 Date of last shipment of authentic product from Ortho Biotech: 08/19/2002 Date of last shipment of authentic product from Ortho Biotech: 09/22/2002
Distribution Status: Authentic product bearing this lot number may be in the distribution chain. Distribution Status: Based on historical usage patterns and inventory practices, it is likely that virtually all authentic PROCRIT with this lot number has already been used. Distribution Status: Based on historical usage patterns and inventory practices, it is likely that virtually all authentic PROCRIT with this lot number has already been used.

 

The packaging of counterfeit product labeled as PROCRIT bearing lot numbers P007645 and P004677 deviates from authentic PROCRIT packaging in several ways (see photos). One area of distinction is that authentic product bears a carton closure seal, that when removed, leaves a visible mark on the package. The authentic seal has "OBPLP VOID" printed in a random sequence on the underside of the seal which is visible upon removal. Counterfeit product seals leave no visible mark on the package upon removal and have no printing on the underside of the seal. See pictures 3a and 3b for more detail. It has also been reported that counterfeit vials bearing lot number P004839 have been discovered in counterfeit cartons bearing lot number P007645. All PROCRIT cartons and vials should be carefully examined for authenticity.

Physicians, pharmacists, nurses and all other healthcare professionals should carefully examine all PROCRIT packaging and vials before use.

In addition, healthcare providers with access to patient information indicating that a patient could be in possession of counterfeit product labeled as PROCRIT bearing these lot numbers, should contact such patients and provide them with this information.

If you receive any product labeled as PROCRIT that you suspect is counterfeit or that bears any of these counterfeit characteristics, do not use the product. Please quarantine and store the product under labeled conditions. Promptly contact Ortho Biotech Medical Information at 1 (800) 325-7504, prompt #2. You also may contact the FDA at 1 (800) 835-4709, prompt #1, then #5 for further instructions.

Ortho Biotech is cooperating fully with the FDA and others investigating this matter to prevent further distribution of counterfeit product. If you become aware of or are offered any Ortho Biotech product from a source other than an approved Ortho Biotech wholesaler/distributor, immediately contact Ortho Biotech at the number listed above.

Ortho Biotech continues to be committed to taking aggressive measures in order to help protect the quality and integrity of its products. As such, we are reminding you of our current policy: Any direct account that purchases PROCRIT or any other Ortho Biotech product from a source other than Ortho Biotech will have their direct account status terminated immediately. Hospitals, retail pharmacies and physicians offices may want to consider having their distributor/wholesaler sign a document that guarantees all Ortho Biotech product is purchased directly from Ortho Biotech.

Additionally, a number of companies are now offering PROCRIT and other biological products in pre-filled syringes to hospitals, pharmacies, and physician’s offices. These companies draw up product from the original product vial into a pre-filled syringe and provide it to hospitals or offices by courier or express mail service. The inability to authenticate the product at the end-user site is a major concern with this practice along with exposure to out of range temperatures, questions of sterility/contamination, and vibration of the protein during shipping that may lead to alterations in stability. Ortho Biotech does not endorse or condone this practice. As such, the repackaging center and the customer of such services assume all risk associated with this practice.

Full product information, a listing of approved Ortho Biotech wholesalers/distributors and updates on this situation are available at http://www.procrit.com/ and the United States link at http://www.orthobiotech.com/. For those who do not have Internet access, please contact Ortho Biotech Medical Information at 1 (800) 325-7504, prompt #2.

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

Mark A. Klausner, M.D.
Vice President, Internal Medicine
Clinical Affairs
Ortho Biotech Products, L.P.

 

Comparison of Features of Authentic PROCRIT and Counterfeit Product Bearing Lot Number P004677, expiration 02/2004.
Comparison of Features of Authentic PROCRIT and Counterfeit Product 1
Photo 1

 

 Comparison of Features of Authentic PROCRIT and Counterfeit Product Bearing Lot Number P004677, expiration 02/2004.
Comparison of Features of Authentic PROCRIT and Counterfeit Product 2
Photo 2

 

 Comparison of Features of Authentic PROCRIT and Counterfeit Product Bearing Lot Number P007645, expiration 10/2004; P004677, expiration 02/2004.
Comparison of Features of Authentic PROCRIT and Counterfeit Product 3
  Photo 3a

 

 Comparison of Features of Authentic PROCRIT and Counterfeit Product Bearing Lot Number P007645, expiration 10/2004; P004677, expiration 02/2004.
Comparison of Features of Authentic PROCRIT and Counterfeit Product 4
  Photo 3b

 

 Comparison of Features of Authentic PROCRIT and Counterfeit Product Bearing Lot Number P007645, expiration 10/2004.
Comparison of Features of Authentic PROCRIT and Counterfeit Product 5
Photo 4

 

 Comparison of Features of Authentic PROCRIT and Counterfeit Product Bearing Lot Number P007645, expiration 10/2004; P004677, expiration 02/2004.
Comparison of Features of Authentic PROCRIT and Counterfeit Product 6
Photo 5

 

 Comparison of Features of Authentic PROCRIT and Counterfeit Product Bearing Lot Number P007645, expiration 10/2004; P004677, expiration 02/2004.
Comparison of Features of Authentic PROCRIT and Counterfeit Product 8
Photo 6
 Comparison of Features of Authentic PROCRIT and Counterfeit Product Bearing Lot Number P007645, expiration 10/2004.
Comparison of Features of Authentic PROCRIT and Counterfeit Product 9
Photo 7

 

 Comparison of Features of Authentic PROCRIT and Counterfeit Product Bearing Lot Number P004677, expiration 02/2004.
Comparison of Features of Authentic PROCRIT and Counterfeit Product 10
Photo 8

 

 Comparison of Features of Authentic PROCRIT and Counterfeit Product Bearing Lot Number P007645, expiration 10/2004.
Comparison of Features of Authentic PROCRIT and Counterfeit Product 11
Photo 9

 

 Comparison of Features of Authentic PROCRIT and Counterfeit Product Bearing Lot Number P004677, expiration 02/2004.
Comparison of Features of Authentic PROCRIT and Counterfeit Product 12
Photo 10b

 

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