Home/Recalls/FDA-99463
FDA DrugsNot Yet Classified

Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.

Published: August 19, 2026Category: drugsCountry: US
US
PharmaceuticalFDA DrugsUSUS

Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.

Recalling Firm: Baxter Healthcare Corporation

Reason for Recall / Hazard

Presence of Particulate Matter

Product Description & Identification

Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.

Additional Source Details

FieldValue
CityDeerfield
StateIL
Openfda › UniiP380M0454Z
Openfda › RouteINTRAVENOUS
Openfda › Rxcui › 11665050
Openfda › Rxcui › 21665060
Openfda › Rxcui › 32630753
Openfda › Spl id9139fd65-24ba-42a9-a084-9d6dd2d1b181
Openfda › Brand nameCEFAZOLIN
Openfda › Spl set idd91a8d13-99a0-4d87-88dc-71cbd37922b4
Openfda › Package ndc › 10338-3508-41
Openfda › Package ndc › 20338-3503-41
Openfda › Package ndc › 30338-0096-06
Openfda › Product ndc › 10338-0096
Openfda › Product ndc › 20338-3508
Openfda › Product ndc › 30338-3503
Openfda › Generic nameCEFAZOLIN SODIUM
Openfda › Product typeHUMAN PRESCRIPTION DRUG
Openfda › Substance nameCEFAZOLIN SODIUM
Openfda › Manufacturer nameBaxter Healthcare Corporation
Openfda › Application numberNDA207131
Openfda › Is original packagertrue
Event id99463
Address 11 Baxter Pkwy
Code infoLot # LD175708, Exp Date: 14-Feb-2027.
Postal code60015-4625
Report date20260819
Product typeDrugs
Reason for recallPresence of Particulate Matter
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260724
Initial firm notificationLetter

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Overview

  • Recalling FirmBaxter Healthcare Corporation
  • StatusOngoing
  • Risk LevelNot Yet Classified
  • DistributionUS Nationwide.
Recall Hazard Severity
Caution (Class III)
Official Agency Alert

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🚨 SAFETY ALERT: Baxter Healthcare Corporation - Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.

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Spread the WordCefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.

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