Class 2 medicines recall: Action within 48 hours – batches of Irbesartan / Hydrochlorothiazide tablets (Actavis)

04 Jan 2019

A Class 2 medicines recall has been issued for certain batches of both strengths of Irbesartan / Hydrochlorothiazide tablets by Actavis Group PTC EHF

DRUG ALERT

Class 2 medicines recall – Action within 48 hours

Ref: EL (19) A/01

Date 3 January 2019

Irbesartan / Hydrochlorothiazide tablets
(Manufactured by Actavis Group PTC EHF )

PL 30306/0266 and PL 30306/0265

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

Irbesartan / Hydrochlorothiazide 150/12.5mg Film-coated Tablets,

PL 30306/0265

 Batch number Expiry date Pack size Date of first distribution
150118 30/04/2020 1 x 28 12/09/2018

 

Irbesartan/

Hydrochlorothiazide 300/12.5mg Film-coated Tablets,

PL 30306/0266

 Batch number Expiry date Pack size Date of first distribution
059118 31/03/2020 1 x 28 17/09/2018
099218 31/03/2020 1 x 28 04/10/2018
191418 31/05/2020 1 x 28 25/10/2018

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.