FDA Recall D-0058-2023
Viatris Inc · Canonsburg, PA
Class I — life-threatening Terminated 462 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0058-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2022-10-07
- Classified by FDA Center
- 2022-11-08
- FDA published
- 2022-11-16
- Terminated
- 2024-01-12
- Recalling firm
- Viatris Inc
- Firm location
- Canonsburg, PA
Drug identification
- Brand name(s)
- OCTREOTIDE ACETATE
- Generic name(s)
- OCTREOTIDE ACETATE
- Manufacturer(s)
- Mylan Institutional LLC
- NDC(s)
67457-239, 67457-245, 67457-246- Route(s)
- INTRAVENOUS, SUBCUTANEOUS