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October 26, 1999

Marsam Pharmaceuticals, Inc. Recalls Nafcillin Sodium , Ampicillin Sodium, and Cefazolin Sodium

Cherry Hill, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Marsam Pharmaceuticals is recalling certain Rx semi-synthetic penicillin drugs derived from the penicillin nucleus for IM or IV administration because of unapproved (ANDA) raw material assay calculations (averaging).

This ongoing recall was initiated by the company on June 6, 1999 by letter.  This is the first notice the FDA has issued to the general public of the recall.

The recalled drugs are:
a) Nafcillin Sodium for Injection, USP, 500 mg, 6 mL vial, Control/Lot No. 7L02199
b) Nafcillin Sodium for Injection, USP, 1g, 20 and 100 mL vials;
c) Nafcillin Sodium for Injection, USP, 2g, 20 and 100 mL vials;
d) Nafcillin Sodium for Injection, USP,10g, 100 mL vial, 4 lot numbers
e) Ampicillin Sodium, USP Sterile, 1g, 10mL vial, Rx synthetic penicillin indicated for treatment of moderately severe and severe infections caused by susceptible strains of numerous (mostly gram-positive, but also specific gram-negative) organisms for IM or IV administration;
f) Cefazolin Sodium, USP, Sterile, 1 gram, 10 mL vial, Rx a semi-synthetic cephalosporin for IM or IV administration and is indicated in the treatment of serious infections.

Over 38,000 Trays of these medicines were distributed nationwide and Canada.  (a-d) were distributed Nationwide,  (e) was distributed in Canada, (f) was distributed Nationwide.  They can be identified by the following codes:

Nafcillin Sodium for Injection:
Lot # 9712026 (Control # 7L02199), EXP 11/2000- NDC 0209-6900-22
Lot # 9701040 (Control # 7A01645), EXP 01/2000-NDC 0209-6950-22
Lot # 9710018 (Control # 7J02067), EXP 09/2000- NDC 0209-6950-22
Lot # 9712024 (Control # 7L02191), EXP 11/2000- NDC 0209-6950-22
Lot # 9711030 (Control # 7K02143), EXP 10/2000- NDC 0209-6950-22
Lot # 9710049 (Control # 7J02100), EXP 09/2000- NDC 0209-7000-42
Lot # 9702001 (Control # 7B01647), EXP 02/2000- NDC 0209-7100-22
Lot # 9702002 (Control # 7B01648), EXP 02/2000- NDC 0209-7100-22
Lot # 9802031 (Control # 8A12261), EXP 01/01- NDC 0209-7100-22
Lot # 9711015 (Control # 7K02121), EXP 10/2000- NDC 0209-7150-42
Lot # 9701037 (Control # 7A01643), EXP 01/2000- NDC 0209-7250-52
Lot # 9701038 (Control # 7A01644), EXP 01/2000- NDC 0209-7250-52
Lot # 9703050 (Control # 7C01722), EXP 03/2000- NDC 0209-7250-52
Lot # 9711019 (Control # 7K02125), EXP 10/2000- NDC 0209-7250-52.

Ampicillin Sodium:
Lot #9809031 (Control #8H12564) EXP 08/01- NDC 0209-0250-22;
Lot #9807019 (Control #8F02494) EXP 00 JN- no NDC number
Lot #9806017 (Control #8E02493) EXP 00 MA- no NDC number

Cefazolin Sodium:
Lot #9806023 (Control #8E02431) EXP 05/2000 - NDC 0209-0900-24
Lot #9705027 (Control #7E91814) EXP 05/99- NDC 0209-1000-42

(Note: the Control Number identifies All products on the label. 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

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