Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences

SafetyAlerts
October 26, 1999

Marsam 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) EXP 12/01
NDC 0209-8580-22

b) Lot #9806019 (Control #8E02475) EXP. 00 MA

c) Lot #9810030 (Control #8J02600) EXP 09/2000
NDC 0209-1132-22

d) Lot#9902058 (Control #9A12836) EXP 01/01
NDC 0209-0900-20
Lot #9902059 (Control #9A12837) EXP 01/01
NDC 0209-0900-20
Lot #9805020 (Control #8D02403) EXP 04/2000
NDC 0209-1000-42

e) Lot #9902054A (Control #9A12833) EXP 01 JA
Lot #9902054B (Control #9A22834) EXP 01/2002
NDC 0209-0100-22

f) Lot #9902053A (Control #9A12831) EXP 01 JA
Lot #9902053B (Control #9A22832) EXP 01/2002
NDC 0209-0150-22

g) Lot #9704019 (Control #7D01760) EXP 04/00
NDC 0209-8300-52

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.

###

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.