Drug recall D-0405-2026
Product
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 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 0480-9259-08.
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: 4401491, 4401600, 4401603, 4401629, Exp.: 9/31/2026; 4500594, 4500786, 4500920, 4501007, 4501462, Exp.: 3/31/2027.
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Quantity
- 19,869 Cartons
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 17, 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.