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%

Source: MHRA/ Gov.uk

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.

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