Class 4 Medicines Defect Information: CNX Therapeutics Ltd, Latuda film-coated tablets, EL (22)A/13
CNX Therapeutics Ltd. have notified the MHRA that the batches of Latuda film-coated tablets listed in this notification will be released without EAN barcodes on the cartons.
MDR Number
MDR 250-01/22
Company name
CNX Therapeutics Ltd
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)
Brief description of the 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 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.
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.
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.
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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