95%Confidence
0Views
FDASource
2026-04-08Date
Summary
The third Class II recall for Teva's Octreotide Acetate (30 mg) confirms widespread sterility assurance failures at Pharmathen International, affecting multiple dosage strengths. This pattern suggests significant regulatory and operational challenges that could lead to broader FDA sanctions.
Actionable: Review Teva's overall quality management system and consider the risk of further regulatory actions against the company.
AI Confidence: 95%
Data Points
firmTeva Pharmaceuticals USA, Inc
classificationClass II
statusOngoing
distributionNationwide in the USA
productOctreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmat
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