FDARecalled Apr 1, 2026 · #D-0406-2026
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 Gr...
Hazard
Class II — temporary health risk
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Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. Classification: Class II Distribution: Nationwide in the USA
Product details
- 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.
- Type
- Drugs
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Model numbers
- 4400401
- UPCs
- —