Company led medicines recall: Irinotecan 200mg/ 260mL in sodium chloride 0.9% w/v intravenous infusion and Infliximab (Remsima) intravenous infusion in sodium chloride 0.9%
Qualasept Ltd t/a Bath ASU is recalling a specific batch of Irinotecan 200mg/260mL in sodium chloride 0.9% w/v intravenous infusion and specific batches of Infliximab (Remsima) Intravenous infusion in Sodium Chloride 0.9%w/v due to risks of reduced product quality.
CLMR Number
CLMR (21)A/07
MDR Number
MDR 085-10/21 - Irinotecan 200mg/ 260mL in sodium chloride 0.9% w/v intravenous infusion
MDR 178-10/21 - Infliximab (Remsima) intravenous infusion in sodium chloride 0.9%
Company Name
Qualasept Ltd t/a Bath ASU (MS 29581)
Product description
Irinotecan 200mg/ 260mL in sodium chloride 0.9% w/v intravenous infusion
Infliximab (Remsima) intravenous infusion in sodium chloride 0.9%
Lot Number/Expiry
Irinotecan 200mg/ 260mL in sodium chloride 0.9% w/v intravenous infusion
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 21H1488A | 10 November 2021 | 5 bags | 1 September 2021 |
Infliximab (Remsima) intravenous infusion in sodium chloride 0.9%
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 21K0361A | 29 December 2021 | 1 bag | 6 October 2021 |
| 21K0361B | 29 December 2021 | 1 bag | 6 October 2021 |
| 21K0361C | 29 December 2021 | 1 bag | 6 October 2021 |
| 21K0361D | 29 December 2021 | 1 bag | 6 October 2021 |
| 21K0361E | 29 December 2021 | 1 bag | 6 October 2021 |
| 21K0361F | 29 December 2021 | 1 bag | 6 October 2021 |
| 21K0361G | 29 December 2021 | 1 bag | 6 October 2021 |
| 21K0361H | 29 December 2021 | 1 bag | 6 October 2021 |
| 21K0361J | 29 December 2021 | 1 bag | 6 October 2021 |
| 21K0361K | 29 December 2021 | 1 bag | 6 October 2021 |
| 21K0361L | 29 December 2021 | 1 bag | 6 October 2021 |
| 21K0361M | 29 December 2021 | 1 bag | 6 October 2021 |
| 21K0361N | 29 December 2021 | 1 bag | 6 October 2021 |
| 21K0361P | 29 December 2021 | 1 bag | 6 October 2021 |
Brief Description of Problem
Irinotecan 200mg/ 260mL in sodium chloride 0.9% w/v intravenous infusion
Qualasept Ltd t/a Bath ASU is recalling the above batch of Irinotecan 200mg/260mL in sodium chloride 0.9% w/v intravenous infusion, due to a risk of reduced product stability resulting from potential exposure to light during the manufacturing process that has exceeded the recommended duration specified.
This product is supplied to hospital pharmacies only.
Remaining stock of the above batch should be quarantined and returned to the company once replacement stock is available for use on site.
Infliximab (Remsima) intravenous infusion in sodium chloride 0.9%
Qualasept Ltd t/a Bath ASU is recalling the above batches of Infliximab (Remsima) Intravenous infusion in Sodium Chloride 0.9%w/v due to a risk of reduced product sterility resulting from the use of expired filters during the manufacturing process.
This product is supplied to hospital pharmacies only.
Remaining stock of the above batches should be quarantined and 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 Maria Connolly:
Tel: 01225 811131
Company Contact for stock enquiries
For stock information enquiries,
Tel: 01225 811131