Class 2 medicines recall – Action within 48 hours – Irbesartan tablets 150mg and 300mg (Macleods Pharma UK Limited)

25 Jan 2019

A Class 2 medicines recall has been issued for certain batches Irbesartan tablets 150mg and 300mg by Macleods Pharma UK Limited

DRUG ALERT

Class 2 medicines recall – Action within 48 hours

Ref: EL (19)A/02

Date 24 January 2019

Irbesartan tablets 150mg and 300mg
(Manufactured by Macleods Pharma UK Limited )

  • PL 34771/0079 (150mg)
  • PL 34771/0080 (300mg)

 

A Class 2 medicines recall has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for certain batches of Irbesartan tablets 150mg and 300mg as follows:

 

Irbesartan tablets 150mg

PL 34771/0079

Batch number Expiry date Pack size Date of first distribution
EIZ807A July 2021 1 x 28 21/11/2018

 

 

Irbesartan tablets 300mg

PL 34771/0080

Batch number Expiry date Pack size Date of first distribution
EIA1813A July 2021 1 x 28 31/10/2018
EIA1811A July 2021 1 x 28 31/10/2018

 

The medicines recall is a precautionary measure that has been put into place due to potential contamination of the affected batches with N-nitrosodiethylamine (NDEA).

 

Further information can be found on the MHRA section on the GOV.UK website.


Produced by the NPA Pharmacy Services team January 2019.