October 26, 1999Marsam Pharmaceuticals,
Inc. Recalls Penicillin, Cefuroxime Sodium, Ampicillin Sodium and Oxacillin Sodium
Cherry Hill, NJ (SafetyAlerts) - The Food and Drug Administration (FDA)
today reported that Marsam Pharmaceuticals is recalling certain drugs because microbial
contamination was revealed during initial sterility testing (at release).
This ongoing recall was initiated by
the company on July 7, 1999 by letter. This is the first notice the FDA has issued
to the general public of the recall.
The recalled drugs are:
a) Penicillin G Potassium
for Injection, 20 Million Units, 100 mL vial, Rx bactericidal for IM or IV use.
b) Cefuroxime Sodium,
USP, Sterile, 1.5 grams, 20 mL vial, Rx semi-synthetic broad spectrum cephalosporin
antibiotic for IM or IV use
c) Cefuroxime Sodium,
USP, Sterile, 750 mg, 10 mL vial, Rx semi-synthetic broad spectrum cephalosporin
antibiotic for IM or IV use.
d) Cefazolin Sodium,
USP, Sterile, 1 gram, 10 mL vial, Rx semi-synthetic cephalosporin for IM or IV use
e) Ampicillin Sodium,
USP, Sterile, 250 mg, 6 mL vial, Rx synthetic penicillin for IM or IV use
f) Ampicillin Sodium,
USP, Sterile, 500 mg, 6 mL vial, Rx synthetic penicillin for IM or IV use
g) Oxacillin Sodium for
Injection, USP, 10 grams, 100 mL vial, Rx penicillinase-resistant, acid
resistant, semi-synthetic penicillin.
Over 45,000 Trays of these medicines
were distributed nationwide and Canada. They can be identified by the folling codes:
a) Lot #9801015 (Control #8M12221)
b) Lot #9806019 (Control #8E02475)
EXP. 00 MA
c) Lot #9810030 (Control #8J02600)
d) Lot#9902058 (Control #9A12836) EXP
Lot #9902059 (Control #9A12837) EXP 01/01
Lot #9805020 (Control #8D02403) EXP 04/2000
e) Lot #9902054A (Control #9A12833)
EXP 01 JA
Lot #9902054B (Control #9A22834) EXP 01/2002
f) Lot #9902053A (Control #9A12831)
EXP 01 JA
Lot #9902053B (Control #9A22832) EXP 01/2002
g) Lot #9704019 (Control #7D01760)
Note: All products are identified on
the label by the Control Number. The firm's lot number does not appear on the label.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA
Safety Alerts compiles
comprehensive safety recall information for the United States. SafeMail is a free email
service to warn consumers of faulty products and contaminated foods. For complete
information regarding current recalls, past recalls and timely product warning
notification visit: www.safetyalerts.com.