United StatesOctreotide Acetate for Injectable Suspension 30 mg single‑dose kits for gluteal intramuscular use (kit NDC 0480-9262-08; vial label 0480-9260-01; lot 45011002; exp. 03/31/2027) containing an 8‑mL 30 mg vial, a prefilled 2 mL diluent syringe, one vial adapter and one sterile 19‑gauge safety needle are affected. Teva Pharmaceuticals is recalling 2,200 kits distributed nationwide because quality system deficiencies identified during an FDA inspection resulted in a lack of assurance of sterility.
What's being recalled
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.
Recalling firm: Teva Pharmaceuticals USA, Inc, Parsippany, NJ, United States.
How to identify it
Lot: 45011002, Exp. 03/31/2027
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)