Company led medicines recall: Advanced Accelerator Applications NETSPOT (Kit for the preparation of gallium Ga 68 dotatate injection) [unlicensed medicine], CLMR (22)A/02

Source: MHRA / 16.3.22

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 30/09/2022 1 24/02/2022

Active Pharmaceutical Ingredient: 40mcg dotatate

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:

Company contact for stock enquiries

For more stock information please contact Jane Farr:

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