96%Confidence
0Views
FDASource
2026-04-15Date
Summary
Amneal's product mix-up between magnesium sulfate and tranexamic acid IV bags represents a critical medication error risk with potential for patient harm. This serious manufacturing control failure could trigger regulatory sanctions and affect hospital contracts.
Actionable: Recall affected IV bag lots immediately and audit all injectable products from this manufacturing facility.
AI Confidence: 96%
Data Points
firmAmneal Pharmaceuticals, LLC
classificationNot Yet Classified
statusOngoing
distributionU.S.A. Nationwide
productMagnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Am
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