Teva Pharmaceuticals Octreotide Acetate Class II Sterility Recall
Summary
The FDA announced a Class II recall of Teva Pharmaceuticals' Octreotide Acetate for Injectable Suspension 10mg single-dose vials due to lack of sterility assurance. Quality system deficiencies were identified at the contract manufacturer Pharmathen International S.A. in Greece during a routine FDA inspection. The recall affects products distributed nationwide in the USA and is currently ongoing.
What changed
Teva Pharmaceuticals USA initiated a voluntary Class II recall for Octreotide Acetate for Injectable Suspension 10mg (single-dose 8mL vials) distributed nationwide. The recall was triggered by quality system deficiencies identified at the contract manufacturer Pharmathen International S.A. in Greece during a routine FDA inspection, raising concerns about sterility assurance of the product.\n\nHealthcare providers and distributors should immediately identify and quarantine any affected product in their inventory and cease administration. Pharmacies and healthcare facilities should notify patients who may have received this medication. The recall is ongoing and no specific return deadline was provided. Adverse reactions or quality problems should be reported to the FDA MedWatch program.
What to do next
- Identify and quarantine all Octreotide Acetate 10mg vials from affected lots in inventory
- Cease administration of recalled product and notify affected patients
- Report any adverse events or quality issues to FDA MedWatch
Source document (simplified)
Teva Pharmaceuticals USA, Inc
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0404-2026 · 20260401 · Ongoing
Product
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, M...
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.
Distribution
Nationwide in the USA
Source: openFDA Enforcement API
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