FDA DrugsClass II
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 ...
Published: April 1, 2026Recall ID: D-0406-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Parsippany |
| State | NJ |
| Openfda › Route | INTRAMUSCULAR |
| Openfda › Rxcui › 1 | 898589 |
| Openfda › Rxcui › 2 | 898601 |
| Openfda › Rxcui › 3 | 898605 |
| Openfda › Spl id | 2e77a034-b0ae-4694-8ac0-ae1319754d3a |
| Openfda › Brand name | OCTREOTIDE ACETATE |
| Openfda › Spl set id | d9739ea6-74de-4a41-a806-6e827a23cedb |
| Openfda › Package ndc › 1 | 0480-9257-08 |
| Openfda › Package ndc › 2 | 0480-9256-01 |
| Openfda › Package ndc › 3 | 0480-9263-21 |
| Openfda › Package ndc › 4 | 0480-9259-08 |
| Openfda › Package ndc › 5 | 0480-9258-01 |
| Openfda › Package ndc › 6 | 0480-9262-08 |
| Openfda › Package ndc › 7 | 0480-9260-01 |
| Openfda › Product ndc › 1 | 0480-9257 |
| Openfda › Product ndc › 2 | 0480-9259 |
| Openfda › Product ndc › 3 | 0480-9262 |
| Openfda › Generic name | OCTREOTIDE ACETATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Manufacturer name | Teva Pharmaceuticals, Inc. |
| Openfda › Application number | ANDA210317 |
| Openfda › Is original packager | true |
| Event id | 98609 |
| Address 1 | 400 Interpace Pkwy Bldg A |
| Code info | 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. |
| Postal code | 07054-1120 |
| Report date | 20260401 |
| Product type | Drugs |
| Product quantity | 21,930 Cartons |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260317 |
| Initial firm notification | Letter |
| Center classification date | 20260327 |
Overview
- Recalling FirmTeva Pharmaceuticals USA, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA