PlainRecalls
FDA Drug Critical Class I Terminated

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).

Reported: November 16, 2022 Initiated: October 7, 2022 #D-0058-2023

Product Description

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.

Details

Recalling Firm
Viatris Inc
Units Affected
22400 syringes
Distribution
Nationwide in the USA
Location
Canonsburg, PA

Frequently Asked Questions

What product was recalled?
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).. Recalled by Viatris Inc. Units affected: 22400 syringes.
Why was this product recalled?
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 16, 2022. Severity: Critical. Recall number: D-0058-2023.