Class 2 medicines recall – Action within 48 hours – Irbesartan tablets 300mg and Irbesartan / Hydrochlorothiazide tablets 300/25mg (Actavis Group PTC EHF)

13 Feb 2019

A Class 2 medicines recall has been issued for certain batches of Irbesartan tablets 300mg and Irbesartan / Hydrochlorothiazide tablets 300/25mg by Actavis Group PTC EHF

DRUG ALERT

Class 2 medicines recall – Action within 48 hours

Ref: EL (19) A04

Date 13 February 2019

Irbesartan tablets 300mg and Irbesartan / Hydrochlorothiazide tablets 300/25mg
(Manufactured by Actavis Group PTC EHF)

PL 30306/0108 (300mg)

PL 30306/0267 (300/25mg)

A Class 2 medicines recall has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for certain batches of Irbesartan tablets 300mg and Irbesartan / Hydrochlorothiazide tablets 300/25mg as follows:

Irbesartan film-coated tablets 300mg

PL 30306/0108

 Batch number

 

 

 Expiry date Pack size Date of first distribution
191018 May 2020 1 x 28 30/11/2018
191118 May 2020 1 x 28 20/12/2018

 

Irbesartan/ Hydrochlorothiazide film-coated tablets 300/25mg

PL 30306/0267

 Batch number Expiry date Pack size Date of first distribution
263918 June 2020 1 x 28 21/11/2018

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 February 2019.