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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.