Class 4 Medicines Defect Information: Latuda film-coated tablets (CNX Therapeutics Ltd)

Class 4 Medicines Defect Information: Latuda film-coated tablets (CNX Therapeutics Ltd)

Drug alert number: EL (22)A/13

Date issued: 14 March 2022

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Latuda film-coated tablets (CNX Therapeutics Ltd)

Brief description of the problem

CNX Therapeutics Ltd. have notified the MHRA that the below listed batches of Latuda film-coated tablets will be released without EAN barcodes on the cartons. The batch numbers and the expiry dates are present and clearly visible on the cartons and on the blisters. Although fully in line with the Marketing Authorisation, the absence of the barcodes may lead to queries as these may sometimes be used for stock control and automated dispensing.

This stock has not yet been distributed, however due to the consideration for stock control and automated dispensing, this notification is being shared in advance of distribution from CNX Therapeutics Ltd to wholesalers and pharmacies. The expected distribution dates for these batches will take place between April 2022 and July 2022.

Product description

Latuda 18.5mg film-coated tablets PLGB 19635/00035

Batch Number Expiry Date Pack Size First Distributed
0011 30 August 2025 28 Not Yet Distributed
0013 31 December 2025 28 Not Yet Distributed

Latuda 37mg film-coated tablets PLGB 19635/0004

Batch Number Expiry Date Pack Size First Distributed
0020 30 November 2025 28 Not Yet Distributed
0021 30 November 2025 28 Not Yet Distributed

Latuda 74 mg film-coated tablets PLGB 19635/0005

Batch Number Expiry Date Pack Size First Distributed
0029 31 December 2025 28 Not Yet Distributed
0030 31 December 2025 28 Not Yet Distributed
0031 31 March 2025 28 Not Yet Distributed

Active Pharmaceutical Ingredient: Lurasidone (as lurasidone hydrochloride)

Advice for healthcare professionals

Wholesalers and healthcare professionals should refer to the batch number and expiry date printed on the carton for stock control and dispensing. The impacted products are within specification and there is no issue with product quality and are not being recalled.

View full alert here

Further Information

For more information and medical information contact: medinfo@cnx-therapeutics.com

For stock control queries please contact: supplychain@cnx-therapeutics.com

Support the call for more funding by recording information about the informal advice you provide to patients over just one day.

Click Here