FDA-Drug2026-09-09Class IIPROCESSING DEFECT
Baxter Pantoprazole Sodium injection recalled for manufacturing quality deviations
What this means
Baxter Healthcare Corporation is recalling one lot of Pantoprazole Sodium in 0.9% Sodium Chloride Injection due to deviations from current good manufacturing practices (CGMP). The affected lot was distributed in the United States, Puerto Rico, and Chile.
- Check your facility inventory for lot NC194129 with expiration date 05/07/2028.
- Do not use this lot; quarantine and return it to your supplier or Baxter Healthcare Corporation.
- Contact your pharmacy, hospital, or medical supplier for instructions on replacement product.
The agency's original wording
Hazard
CGMP Deviations
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide; Puerto Rico; and Chile.
Affected count
N/A
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-9648-12.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0812-2026More Baxter recalls
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Drug2026-09-09Baxter Clindamycin Phosphate injection recalled for manufacturing compliance deviations
- FDA-Drug2026-09-09Baxter Vancomycin Injection recalled for CGMP manufacturing deviations
- FDA-Drug2026-09-09Baxter Clindamycin Injection recalled for manufacturing quality deviations
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