Reported May 13, 2026 · Ongoing
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing:…
Teva Pharmaceuticals USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA, Inc · 400 Interpace Pkwy Bldg A · Parsippany, NJ · 07054-1120
Is this the product you have?
- Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg
- In Single-Dose kits containing8-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 BYPharmathen International S.A, Rodopi, 69300 Greece
- Manufactured ForTEVA Pharmaceuticals, Parsippany, NJ 07054
- NDC Kit Carton0480-9262-08
- Vial Label0480-9260-01
- Tray Label0480-9262-08
- Diluent Label0480-9263-21
- Lot codes and dates
- Lot
45011002Exp. 03/31/2027
- Lot
- Amount recalled
- 2,200 kits
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
This product could cause temporary or reversible health problems — stop using it.
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