FDA recall D-0058-2023

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-10-07

Report date

2022-11-16

Termination date

2024-01-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Canonsburg, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0058-2023