FDAFDA · Food and drugs·Recall number D-0404-2026
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08.
Published April 1, 2026 · Recall initiated: March 17, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- OCTREOTIDE ACETATE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Distributor
- Nationwide in the USA
- Lot
- Lot: 4401619, Exp.: 09/30/2026; 4501005, 03/31/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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