Drug recall D-0519-2026
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 for recall
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Lots and codes
Lot: 45011002, Exp. 03/31/2027
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Quantity
- 2,200 kits
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 24, 2026
Related products
- Octreotide Acetate – drug information
- NDC 0480-9257 Octreotide Acetate · · Teva Pharmaceuticals, Inc.
- NDC 0480-9259 Octreotide Acetate · · Teva Pharmaceuticals, Inc.
- NDC 0480-9262 Octreotide Acetate · · Teva Pharmaceuticals, Inc.