Why it was recalled
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
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).
Lot numbers, UPCs & expiration codes
Lot #: AJ21002, Exp. 03/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0058-2023
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 7, 2022
- FDA report date
- Nov 16, 2022
- Quantity
- 22400 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Viatris Inc
Original FDA data
Every field from FDA enforcement report D-0058-2023, exactly as published.
Show all FDA fields
- City
- Canonsburg
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 90974
- Address
- 1000 Mylan Blvd
- Code information
- Lot #: AJ21002, Exp. 03/2024
- Postal code
- 15317-5853
- Report date
- Nov 16, 2022
- Product type
- Drugs
- Recall number
- D-0058-2023
- Classification
- Class I
- Recalling firm
- Viatris Inc
- Product quantity
- 22400 syringes
- Termination date
- Jan 12, 2024
- Reason for recall
- Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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).
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 7, 2022
- Initial firm notification
- Letter
- Center classification date
- Nov 8, 2022