HIGH

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...

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

Quick Facts at a Glance

Recall Date
April 24, 2026
Hazard Level
HIGH
Brands
OCTREOTIDE ACETATE, Teva Pharmaceuticals, Inc.
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter

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Full Description

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 needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.. Generic: OCTREOTIDE ACETATE; Brand: OCTREOTIDE ACETATE. Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.. Classification: Class II. Quantity: 2,200 kits. Distribution: Nationwide in the USA

View Original Recall on FDA - Drug Safety

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Product Classification

Product Details

Model Numbers
Lot: 45011002
Exp. 03/31/2027
UPC Codes
0480-9257
0480-9259
0480-9262
+7 more
Affected States
ALL
Report Date
May 13, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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