Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 ...
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, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.
Affected Products
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.
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 | 98810 |
| Address 1 | 400 Interpace Pkwy Bldg A |
| Code info | Lot: 45011002, Exp. 03/31/2027 |
| Postal code | 07054-1120 |
| Report date | 20260513 |
| Product type | Drugs |
| Product quantity | 2,200 kits |
| 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 | 20260424 |
| Initial firm notification | Letter |
| Center classification date | 20260505 |
Overview
- Recalling FirmTeva Pharmaceuticals USA, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA