Company led medicines recall: Irinotecan 200mg/ 260mL in sodium chloride 0.9% w/v i.v. infusion and Infliximab (Remsima) i.v. infusion in NaCL 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.
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
Details of the affected batch:
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 21H1488A | 10-Nov-21 | 5 bags | 01-Sep-21 |
Product description Infliximab (Remsima) intravenous infusion in sodium chloride 0.9%
Details of the affected batches:
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 21K0361A | 29-Dec-21 | 1 bag | 06-Oct-21 |
| 21K0361B | 29-Dec-21 | 1 bag | 06-Oct-21 |
| 21K0361C | 29-Dec-21 | 1 bag | 06-Oct-21 |
| 21K0361D | 29-Dec-21 | 1 bag | 06-Oct-21 |
| 21K0361E | 29-Dec-21 | 1 bag | 06-Oct-21 |
| 21K0361F | 29-Dec-21 | 1 bag | 06-Oct-21 |
| 21K0361G | 29-Dec-21 | 1 bag | 06-Oct-21 |
| 21K0361H | 29-Dec-21 | 1 bag | 06-Oct-21 |
| 21K0361J | 29-Dec-21 | 1 bag | 06-Oct-21 |
| 21K0361K | 29-Dec-21 | 1 bag | 06-Oct-21 |
| 21K0361L | 29-Dec-21 | 1 bag | 06-Oct-21 |
| 21K0361M | 29-Dec-21 | 1 bag | 06-Oct-21 |
| 21K0361N | 29-Dec-21 | 1 bag | 06-Oct-21 |
| 21K0361P | 29-Dec-21 | 1 bag | 06-Oct-21 |
Irinotecan 200mg/ 260mL in sodium chloride 0.9% w/v intravenous infusionBrief description of problem
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 contacts for further information
For medical information enquiries, please contact Maria Connoll : 01225 811131 Maria.connolly@bathasu.com
For stock information enquiries: 01225 811131 customerservices@bathasu.com