Drug 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).
D-0058-2023
Product summary
- Firm
- Viatris Inc
- Event
- Event 90974
- Status
- Terminated
- Classification
- Class I
- Quantity
- 22400 syringes
- Official record key
drug-enforcement:D-0058-2023
Official wording
Reason: Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Code information: Lot #: AJ21002, Exp. 03/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter