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Octreotide Acetate

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Somatostatin Analog

CAS79517-01-4HSN29372900
THERAPEUTIC AREAS
MOLECULE INTELLIGENCE SNAPSHOTlive
19
Manufacturers monitored
3
Intelligence briefs
2
Active regulatory actions
1
HSN code

INTELLIGENCE

Showing 3 of 3 briefs for Octreotide Acetate
REGULATORY INTELLIGENCE·Warning Letter

Teva Pharmaceuticals Recalls Octreotide Acetate Due to Sterility Concerns at Contract Manufacturer Pharmathen

Teva Pharmaceuticals USA, Inc. has initiated a Class II recall of Octreotide Acetate for Injectable Suspension, impacting 2,200 kits nationwide. This action stems from FDA inspection findings at contract manufacturer Pharmathen International S.A. in Greece, revealing critical quality system deficiencies affecting sterility assurance. Procurement and supply chain leaders must assess immediate supply risks and diversify sourcing strategies.

90-Day Activity
CMCatherine Morrow· Senior Regulatory Intelligence Analyst
2026-05-13
REGULATORY INTELLIGENCE·Recall

Teva Pharmaceuticals Recalls 21,930 Octreotide Acetate Cartons Over Sterility Concerns from Greek Manufacturer

Teva Pharmaceuticals USA, Inc. has initiated a nationwide Class II recall of 21,930 cartons of Octreotide Acetate for Injectable Suspension. This critical action stems from a lack of sterility assurance identified during an FDA inspection at its contract manufacturer, Pharmathen International S.A. in Greece, highlighting significant quality system deficiencies impacting patient safety and supply chain integrity.

90-Day Activity
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2026-04-01 Recall
REGULATORY INTELLIGENCE·Warning Letter

Teva Pharmaceuticals' Octreotide Acetate Recall Highlights Critical Sterility Lapses at Greek Contract Manufacturer

Teva Pharmaceuticals USA, Inc. has initiated a Class II recall for 19,869 cartons of Octreotide Acetate for Injectable Suspension. This action stems from critical sterility assurance deficiencies identified by the FDA at its contract manufacturer, Pharmathen International S.A. in Greece. Procurement and regulatory teams must assess supply chain vulnerabilities and review quality oversight protocols for sterile injectables.

90-Day Activity
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2026-04-01 Warning Letter