Company led medicines recall: Advanced Accelerator Applications NETSPOT (Kit for the preparation of gallium Ga 68 dotatate injection) [unlicensed medicine], CLMR (22)A/02
Advanced Accelerator Applications is recalling specific batches of this product as a precautionary measure due to an out of specification result that was identified during stability testing.
CLMR Number
CLMR (22)A/02
MDR Number
MDR 137-03/22
Company name
Advanced Accelerator Applications
Product description
NETSPOT (Kit for the preparation of gallium Ga 68 dotatate injection) [unlicensed medicine]
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| PG1921014 | 16/03/2022 | 1 | 08/08/2021 |
| PG1921015 | 16/03/2022 | 1 | 11/10/2021 |
| PG1921017 | 18/03/2022 | 1 | 02/08/2021 |
| PG1921018 | 11/05/2022 | 1 | 25/10/2021 |
| **PG1921028 | 06/10/2022 | 1 | 24/02/2022 |
Active Pharmaceutical Ingredient: 40mcg dotatate
**Following correction by Advanced Accelerator Applications, an update was made on 22 March 2022 to reflect correction of the expiry date.
Brief description of the problem
An Out-of-Specification (OOS) result was obtained during a stability study.
This recall is being issued as a company-led medicines recall, as this product is only supplied to several hospitals/customers and the manufacturer has full traceability.
The remaining stock of the above batches should be quarantined and returned to the company directly. Arrangements will be been made by Advanced Accelerator Applications to resupply hospital sites with unaffected products.
Company contact for medical enquiries
For more medical information please contact Diane Fogarty: diana.fogarty@novartis.com.
Company contact for stock enquiries
For more stock information please contact Jane Farr: jane.farr@novartis.com.