Safety alertSource: FDA Drug Enforcement Reports

Class II recall: Baxter Healthcare Corporation: Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL)

Baxter Healthcare Corporation initiated a Class II recall of Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) single-dose infusion bags in 100 mL GALAXY containers, NDC 0338-9648-12. The recall notice cites CGMP deviations as the reason for the action.

Most relevant for: Hospital and inpatient care settings using intravenous pantoprazole for acid suppression, such as in patients with GI bleeding or those unable to take oral medications.

Read the original at FDA Drug Enforcement Reports

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