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 Strength, A ...
Recall Summary Teva Pharmaceuticals is recalling Octreotide Acetate 30 mg injectable suspension kits nationwide due to quality system problems at the manufacturer that raise concerns about whether the product is sterile. This medication is used for intramuscular injection and is distributed across all U.S. states. The recall was triggered after the FDA found deficiencies during a routine inspection of the manufacturing facility in Greece.
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Product
- 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.
- 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
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-24
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/fe1c2eb8-bf32-44fc-be4b-937a61f215a1