Company led medicines recall: LysaKare 25 g / 25 g solution for infusion (PLGB 35145/0005)
Advanced Accelerator Applications (UK & Ireland) Ltd is recalling a specific batch as it was identified during the inspection process by the manufacturer that a small number of bags were observed to be leaking.
CLMR Number
CLMR (21)A/03
MDR Number
MDR 081-05/21
Company Name
Advanced Accelerator Applications (UK & Ireland) Ltd.
Product description
LysaKare 25 g / 25 g solution for infusion (PLGB 35145/0005)
Lot Number/Expiry
| Batch Number | Expiry Date | Pack size | First distributed |
|---|---|---|---|
| 210155 | 02/2023 | 1x 1000 ml bag | 6 April 2021 |
Brief description of problem
Advanced Accelerator Applications Ltd is recalling the above batch of LysaKare 25 g / 25 g solution for infusion (PLGB 35145/0005) as it was identified during the inspection process by the manufacturer that a small number of bags were observed to be leaking.
This product is supplied to hospital pharmacies, hospital nuclear medicine & hospital radiopharmacy departments only.
Remaining stock of the above batch should be quarantined. Arrangements have been made by Advanced Accelerator Applications (UK & Ireland) Ltd to resupply the sites with unaffected bags. The affected batch should be returned to the company once replacement stock is available for use on site.
Company contact for medical information enquiries
For medical information enquiries, please contact: Advanced Accelerator Applications (UK & Ireland) Ltd infomed@adacap.com.
Company contact for stock enquiries
For stock information enquiries contact Advanced Accelerator Applications (UK & Ireland) Ltd by emailing: customersvc.aaauk@novartis.com, tel. +44(0)20 72585200