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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