Why it was recalled
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Product description
NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with lyophilized powder), 1 Single dose vial, consisting of 40 mcg of dotate, 5 mcg of 1,10-phenanthroline, 6 mcg of Gentisic acid, 20 mg of D-Mannitol, and Nitrogen; and Vial 2, 1 Single dose vial of reaction buffer, 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 # (Vial 1)/kit: (F03221004 vial) in kit PG1921014, PG1921015, Exp 16-Mar-2022; (F03221005 vial) in kit PG1921016, PG1921017, Exp 18-Mar-2022; (F03221006 vial) in kit PG1921018, PG1921019, Exp 11-May-2022; (F03221007 vial) in kit PG1921020, PG1921021, Exp 04-Aug-2022
Where it was sold
Nationwide in the USA and Puerto Rico
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-0747-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 18, 2022
- FDA report date
- Apr 13, 2022
- Quantity
- 14,089 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Accelerator Applications USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0747-2022, exactly as published.
Show all FDA fields
- City
- Millburn
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89885
- Address
- 57 E Willow St
- Code information
- Lot # (Vial 1)/kit: (F03221004 vial) in kit PG1921014, PG1921015, Exp 16-Mar-2022; (F03221005 vial) in kit PG1921016, PG1921017, Exp 18-Mar-2022; (F03221006 vial) in kit PG1921018, PG1921019, Exp 11-May-2022; (F03221007 vial) in kit PG1921020, PG1921021, Exp 04-Aug-2022
- Postal code
- 07041-1416
- Report date
- Apr 13, 2022
- Product type
- Drugs
- Recall number
- D-0747-2022
- Classification
- Class III
- Recalling firm
- Advanced Accelerator Applications USA, Inc.
- Product quantity
- 14,089 kits
- Termination date
- Jan 4, 2023
- Reason for recall
- Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with lyophilized powder), 1 Single dose vial, consisting of 40 mcg of dotate, 5 mcg of 1,10-phenanthroline, 6 mcg of Gentisic acid, 20 mg of D-Mannitol, and Nitrogen; and Vial 2, 1 Single dose vial of reaction buffer, 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 USA and Puerto Rico
- Recall initiation date
- Mar 18, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2022