Octreotide Acetate Injection 500 mcg/mL — Class I drug recall D-0058-2023
Terminated recall by Viatris Inc, reported 2022-11-16, distributed nationwide. Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
| Recall number | D-0058-2023 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viatris Inc, Canonsburg, PA, United States |
| Recall initiated | 2022-10-07 |
| Classified | 2022-11-08 |
| Reported by FDA | 2022-11-16 |
| Terminated | 2024-01-12 |
| Distributed | Nationwide (US) |
| Quantity | 22,400 syringes |
| Reason classes | foreign material, specification failure |
| NDC | 67457-0239, 67457-0239-00, 67457-0239-01, 67457-0245, 67457-0245-00, 67457-0245-01, 67457-0246, 67457-0246-00, 67457-0246-01 |
| Lot numbers | AJ21002 |
| Expiration dates | 2024-03 |
Product
Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, NDC: 67457-246-00 (syringe), 67457-246-01 (carton).
Reason for recall
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0058-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.