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Teva Pharmaceuticals USA, Inc recalls Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx onl

Recalled April 1, 2026 · FDA recall D-0405-2026 · Teva Pharmaceuticals USA

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. · FDA Class II
Units
19,869 Cartons
Sold at
Nationwide in the USA

Description

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
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 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 0480-9259-08.
Manufacturer(s)
Teva Pharmaceuticals USA, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Teva Pharmaceuticals USA, Inc recalls Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx onl | RecallWatchUSA