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), 67457-24

FDA recall notice · announced November 16, 2022 · Viatris

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: AJ21002, Exp. 03/2024
Quantity: 22400 syringes
Status: Terminated
Products in this recall event:
- 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 (D-0058-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.