FDA-Drug2022-11-16Class I

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).

Viatris Inc
Hazard

Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.

Sold states
Nationwide in the USA
Affected count
22400 syringes
Manufactured in
1000 Mylan Blvd, N/A, Canonsburg, PA, United States
Products
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).

Official notice

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

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