Class 4 Medicines Defect Information: CNX Therapeutics Ltd, Latuda film-coated tablets, EL(22)A/13
MDR Number: MDR 250-01/22
Company name: CNX Therapeutics Ltd
Product description:
Latuda 18.5mg film-coated tablets PLGB 19635/00035
Details of the affected batch:
|
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
|
0011 |
30th Aug 2025 |
28 |
Not Yet Distributed |
|
0013 |
31th Dec 2025 |
28 |
Not Yet Distributed |
Product description:
Latuda 37mg film-coated tablets PLGB 19635/0004
Details of the affected batch:
|
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
|
0020 |
30th Nov 2025 |
28 |
Not Yet Distributed |
|
0021 |
30th Nov 2025 |
28 |
Not Yet Distributed |
Product description:
Latuda 74mg film-coated tablets PLGB 19635/0005
Details of the affected batch:
|
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
|
0029 |
31st Dec 2025 |
28 |
Not Yet Distributed |
|
0030 |
31st Dec 2025 |
28 |
Not Yet Distributed |
|
0031 |
31st March 2025 |
28 |
Not Yet Distributed |
Active Pharmaceutical Ingredient: Lurasidone (as lurasidone hydrochloride)
Brief description of problem:
CNX Therapeutics Ltd. have notified the MHRA that the above 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.
Advice to 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.
Company contacts for further information:
For more information and medical information contact: medinfo@cnx-therapeutics.com
For stock control queries please contact: supplychain@cnx-therapeutics.com
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
To access the full recall:
Class 4 Medicines Defect Information: CNX Therapeutics Ltd, Latuda film-coated tablets, EL (22) A/13