Why it was recalled
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
Product description
NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40.
Lot numbers, UPCs & expiration codes
Lot #: PG1919025, Exp. 07/11/2020; PG1919026, PG1919027, Exp. 07/16/2020.
Where it was sold
Nationwide in the US and Canada
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-0799-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 10, 2020
- FDA report date
- Jan 29, 2020
- Quantity
- 4295 Kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Accelerator Applications USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0799-2020, exactly as published.
Show all FDA fields
- City
- Millburn
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84685
- Address
- 57 E Willow St
- Code information
- Lot #: PG1919025, Exp. 07/11/2020; PG1919026, PG1919027, Exp. 07/16/2020.
- Postal code
- 07041-1416
- Report date
- Jan 29, 2020
- Product type
- Drugs
- Recall number
- D-0799-2020
- Classification
- Class II
- Recalling firm
- Advanced Accelerator Applications USA, Inc.
- Product quantity
- 4295 Kits
- Termination date
- Jul 21, 2023
- Reason for recall
- Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40.
- Distribution pattern
- Nationwide in the US and Canada
- Recall initiation date
- Jan 10, 2020
- Initial firm notification
- Letter
- Center classification date
- Jan 22, 2020