Class 4 medicines defect information – Atrolak XL prolonged-release tablets
12th February 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.