Class II · Posted April 1, 2026 · Started March 17, 2026 · Ongoing
octreotide acetate
- Product
- Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 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 0480-9262-08.
- Firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- 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.
- Lots
- Lot:4400401, Exp.: 6/30/2026; 4401393, 4401494, 4401604, Exp.: 9/31/2026; 4500564, 4500601, 4500707, 4500796, 4500859, 4500918, 4500919, 4501006, Exp.: 3/31/2027.
- Quantity
- 21,930 Cartons
- Distribution
- Nationwide in the USA
- RxNorm
- octreotide acetate (RxCUI 898589, 898601, 898605)
- Recall number
- D-0406-2026