Status
Terminated
Drug Enforcement D-0058-2023
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Classification
Class I
Report Date
November 16, 2022
Termination Date
January 12, 2024
Product Information
- 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).
- Product quantity
- 22400 syringes
- Reason for recall
- Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Viatris Inc
- Address
-
1000 Mylan Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0058-2023
- Event ID
- 90974
- Recall initiation date
- October 7, 2022
- Center classification date
- November 8, 2022
- Code info
- Lot #: AJ21002, Exp. 03/2024
- More code info
- —