Drug product
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 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 0480-9257-08.
D-0404-2026
Product summary
- Event
- Event 98609
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,897 Cartons
- Official record key
drug-enforcement:D-0404-2026
Official wording
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.
Code information: Lot: 4401619, Exp.: 09/30/2026; 4501005, 03/31/2027.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility