97%Confidence
0Views
FDASource
2026-04-14Date
Summary
Amneal's product mix-up between magnesium sulfate and tranexamic acid represents a critical medication error risk with potential for serious patient harm. This unclassified but severe deviation suggests fundamental packaging or labeling failures in their sterile manufacturing operations.
Actionable: Immediately quarantine all affected Amneal IV products and conduct emergency verification of all sterile product labeling.
AI Confidence: 97%
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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