FDA Drug recall D-0058-2023
Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufact…
- FDA Drug
- Class I
- terminated
- Published 2022-11-16
On 2022-11-16 the FDA classified a Class I recall of Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufact… by Viatris, citing presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0058-2023 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-10-07 |
| Published | 2022-11-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Viatris |
| Distribution | US |
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
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Identifiers
| ndc | 67457-239-00 |
|---|---|
| ndc | 67457-239-01 |
| ndc | 67457-245-00 |
| ndc | 67457-245-01 |
| ndc | 67457-246-00 |
| ndc | 67457-246-01 |
| code_info | Lot #: AJ21002, Exp. 03/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0058-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.