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Limited Availability of Penicillin G Sodium

On December 17, 1993, Marsam Pharmaceuticals * (Cherry Hill, New Jersey), the sole manufacturer of Penicillin G Sodium, reported that the supplier of the active ingredient ceased production. As a result, inventories of Penicillin G Sodium for Injection may become low or depleted. Penicillin G Sodium is generally used in patients who cannot tolerate Penicillin G Potassium (e.g., patients with renal impairment).

Most patients requiring parenteral penicillin therapy can tolerate Penicillin G Potassium, of which there is no shortage. Acceptable alternative therapy may be available for many patients with renal impairment; however, physicians should evaluate alternatives on a case-by-case basis.

Marsam Pharmaceuticals and the Food and Drug Administration have identified a new manufacturer of the active ingredient, and required testing is in progress. In the interim, Marsam Pharmaceuticals will retain an emergency supply of Penicillin G Sodium. Physicians who have patients for whom no substitute is acceptable should contact Marsam Pharmaceuticals, telephone (800) 883-2600.

Reported by: Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration.

  • Use of trade names and commercial sources is for identification only and does not imply endorsement by the Public Health Service or the U.S. Department of Health and Human Services.

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