Class 4 medicines defect information – Atrolak XL prolonged-release tablets

12 Feb 2020

DRUG ALERT

Class 4 medicines defect information – Caution in Use – Atrolak XL prolonged-release tablets

Ref: EL (20)A/06

12 February 2020

Atrolak XL prolonged-release tablets 50mg — PL 20075/0213
Atrolak XL prolonged-release tablets 150mg — PL 20075/0446
Atrolak XL prolonged-release tablets 200mg — PL 20075/0214
Atrolak XL prolonged-release tablets 300mg — PL 20075/0215
Atrolak XL prolonged-release tablets 400mg — PL 20075/0216
(Manufactured by Accord Healthcare Ltd)

A Class 4 medicines defect information alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for specific batches and strengths of Atrolak XL (quetiapine fumarate) prolonged-release tablets due to the Patient Information Leaflet (PIL) missing some clinically significant side effects.

Atrolak XL prolonged-release tablets 50mg

Batch number Expiry date Pack size First distributed
322729 May 2021 60 19 December 2019
Y06455 October 2021 60 3 September 2019

Atrolak XL prolonged-release tablets 150mg

Batch number Expiry date Pack size First distributed
Y04771 October 2021 60 6 November 2019
Y04788 October 2021 60 27 September 2019
Y02374 May 2021 60 7 August 2019

 Atrolak XL prolonged-release tablets 200mg

Batch number Expiry date Pack size First distributed
X17653 February 2021 60 24 November 2019
Y06710 August 2021 60 18 November 2019

Atrolak XL prolonged-release tablets 300mg

Batch number Expiry date Pack size First distributed
Y06909 September 2021 60 4 October 2019
X21602 May 2021 60 7 April 2019
X19649 March 2021 60 3 July 2019
X19866 March 2021 60 11 June 2019

 Atrolak XL prolonged-release tablets 400mg

Batch number Expiry date Pack size First distributed
X21825 May 2021 60 10 October 2019
X18765 March 2021 60 5 July 2019

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

Produced by the NPA Pharmacy Services team February 2020.