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In June of 1999, Schein Pharmaceuticals, Inc. (Florham Park, New Jersey) announced that its subsidiary Marsam Pharmaceuticals, Inc. was voluntarily recalling all of its penicillin G (potassium and sodium) for intravenous injection products to address Current Good Manufacturing Practice (CGMP) concerns uncovered during a Food and Drug Administration (FDA) inspection of their manufacturing site. The facility also ceased distribution of penicillin G products on a voluntary basis.

Marsam Pharmaceuticals is a major finished product manufacturer of Penicillin G (potassium and sodium )in the United States. It is unknown when this facility will resume distribution of these products. This situation has caused a shortage of these types of Penicillin G in some parts of the country.

In response to this shortage, FDA has identified a temporary alternate supplier of Penicillin G Sodium. Biochemie GmbH of Kundl, Austria has been granted the ability to temporarily supply Penicillin G (5,000,000 IU) to the United States starting on December 9, 1999. This product will be labeled as distributed by Geneva Pharmaceuticals, Inc. (Broomfield, Co) thus consumers, physicians and hospitals will be able to obtain the product through their normal wholesale suppliers. Limited supplies will be available and Geneva will be operating under a drug shortage allocation program. The use of alternative approved therapies in lieu of Penicillin G for disease treatment where possible is still advised in this shortage situation.

For emergency allocations contact the following:

Jenny Whitehouse, Customer Support Supervisor, at Geneva Pharmaceuticals at:
Telephone: 303-438-4399
Fax: 303-727-4656 or
E-mail: jenny.whitehouse@gx.novartis.com

Eric Lane
Telephone: 303-438-4221
Fax: 303-438-4140 or
E-mail: eric.lane@gx.norvartis.com

Jodi McGowan
Telephone: 303-438-4344
Fax: 303-438-4140 or
E-mail: jodi.mcgowan@gx.norvartis.com

An alternate source of Penicillin G Potassium in frozen bags is Baxter Corporation at www.baxter.com.

FDA will continue to monitor this important health issue until its resolution.

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