Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter - Lack of Assurance of Steril

Source: FDA | Recall date: 05/13/2026

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Affected product: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter

Summary: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U. S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Hazard: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U. S Food and Drug Administration (FDA) inspection at the contract manufacturer.

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