Company led drug alert - Macopharma intravenous infusion bags

Macopharma is recalling certain batches of intravenous infusion bags as a precaution. This is due to the detection of metal particles in two infusion bags.

CLDA Number

CLDA (19)A/03

MDR Number

MDR 59-04/19

Company name

Macopharma

Product description

Various intravenous infusion bags, see list below

Batch Number/ Expiry

See list below

PL Number: PL12580/0008

PRODUCT BATCH Expiry Date
NACL 0,9% 250ML MACOFLEX 17F15A Apr 2020
NACL 0,9% 250ML MACOFLEX 17F23B Apr 2020
NACL 0,9% 250ML MACOFLEX 17L08B Apr 2020
NACL 0,9% 250ML MACOFLEX 18B20C Apr 2020
NACL 0,9% 250ML MACOFLEX 18C08C Apr 2020
NACL 0,9% 250ML MACOFLEX 18D05A Apr 2020
NACL 0,9% 250ML MACOFLEX 18E23A May 2020
NACL 0,9% 250ML MACOFLEX 18F08B Jun 2020
NACL 0,9% 250ML MACOFLEX 18G10A Jul 2020
NACL 0,9% 250ML MACOFLEX 18G11A Jul 2020
NACL 0,9% 500ML MACOFLEX 17L03A Apr 2020
NACL 0,9% 500ML MACOFLEX 17L13B Apr 2020
NACL 0,9% 500ML MACOFLEX 18A16C Apr 2020
NACL 0,9% 500ML MACOFLEX 18A24A Apr 2020
NACL 0,9% 500ML MACOFLEX 18A25A Apr 2020
NACL 0,9% 1000ML MACOFLEX 18B06A Apr 2020
NACL 0,9% 1000ML MACOFLEX 18B08B Apr 2020
NACL 0,9% 1000ML MACOFLEX 18B21B Apr 2020
NACL 0,9% 1000ML MACOFLEX 18B22B Apr 2020
NACL 0,9% 1000ML MACOFLEX 18B23A Apr 2020
NACL 0,9% 1000ML MACOFLEX 18C20A Apr 2020
NACL 0,9% 1000ML MACOFLEX 18D04A Apr 2020

PL Number: PL12580/0007

PRODUCT BATCH Expiry Date
GLUCOSE 10% 500ML MACOFLEX 17K29A Apr 2020
GLUCOSE 10% 500ML MACOFLEX 18E12A May 2020

PL Number: PL12580/0020

PRODUCT BATCH Expiry Date
RINGER LACTATE 500ML 18C26A Apr 2020
RINGER LACTATE 500ML 18D28A Apr 2020
RINGER LACTATE 500ML 18F16A Jun 2020
RINGER LACTATE 1000ML 18B24A Apr 2020
RINGER LACTATE 1000ML 18C27A Apr 2020
RINGER LACTATE 1000ML 18C28A Apr 2020
RINGER LACTATE 1000ML 18F23A Jun 2020

PL Number: PL12580/0006

PRODUCT BATCH Expiry Date
GLUCOSE 5% 250ML EASYFLEX N 18F01A May 2020
GLUCOSE 5% 500ML EASYFLEX N 18D12B Apr 2020

PL Number: PL12580/0006

PRODUCT BATCH Expiry Date
GLUCOSE 5% 250ML MACOFLEX 17I15A Apr 2020
GLUCOSE 5% 250ML MACOFLEX 18B16A Apr 2020

PL Number: PL12580/0008

PRODUCT BATCH Expiry Date
NACL 0,9 %500 ML Easyflex N 18E16A Apr 2020
NACL 0,9% 1000ML Easyflex N 17F14A Apr 2020
NACL 0,9% 250ML 17J26B Apr 2020
NACL 0,9% 250ML 18E17A May 2020

Brief Description of Problem

Macopharma is recalling certain batches of intravenous infusion bags as a precaution, see list above. This is due to the detection of metal particles in two infusion bags. No incidents have been reported in the UK. We understand these products have a fast turnover and that affected batches were delivered through 2017 with the last batch delivered in November 2018. Although it is unlikely that there is much stock remaining in the supply chain, please check your inventory and quarantine any affected stock then notify Macopharma Customer Services, see details below.

Company contact for stock enquiries

Macopharma Customer Services: T: 01332 206022 E: orders@macopharma.co.uk

Company Contact for medical information enquiries

Customer Services as above or clive.richards@spiritmedical.com

Published 8 May 2019