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Recall

Teva Pharmaceuticals USA, Inc: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg stren Recall

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. Product details: 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, and one sterile 1¿ 19-gauge safety injection nee...

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Agency
FDA
Record ID
D-0519-2026
Canonical
https://claimwatch-mvp.vercel.app/item/teva-pharmaceuticals-usa-inc-octreotide-acetate-for-injectable-suspension-for-gluteal-intr/

What happened?

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. Product details: 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, and one sterile 1¿ 19-gauge safety injection nee...

Who may be affected?

Nationwide in the USA

What should consumers do?

Affected quantity: 2,200 kits

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No. This page is informational. Always confirm eligibility, deadlines, and safety instructions through official sources.

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