D-0404-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 1, 2026
- Initiation Date
- March 17, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,897 Cartons
Product Description
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial, 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.
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 4401619, Exp.: 09/30/2026; 4501005, 03/31/2027.