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🏥 FDA: Teva Pharmaceuticals USA, Inc — Class II

healthcarebearishSource: FDA
90%Confidence
0Views
FDASource
2026-04-12Date

Summary

Another Class II recall for Teva's Octreotide Acetate (10 mg) reinforces systemic sterility problems at the same Greek contract manufacturer, signaling broader quality failures across multiple dosage strengths. This recurring issue may necessitate a comprehensive review of Teva's supplier relationships and could result in significant remediation costs.

Actionable: Investigate Teva's contingency plans for alternative manufacturing and consider the long-term impact on its injectables portfolio.

AI Confidence: 90%

Data Points

firmTeva Pharmaceuticals USA, Inc
classificationClass II
statusOngoing
distributionNationwide in the USA
productOctreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmat

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