Class 4 Medicines Defect Information: Pantoprazole 40 mg gastro-resistant tablets (Cadila Pharmaceuticals (UK) Limited)

Class 4 Medicines Defect Information: Pantoprazole 40 mg gastro-resistant tablets (Cadila Pharmaceuticals (UK) Limited)

Drug alert number: EL (24)A/03

Date issued: 30 January 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Pantoprazole 40 mg gastro-resistant tablets (Cadila Pharmaceuticals (UK) Limited)

Company name: Cadila Pharmaceuticals (UK) Limited

Product name: Pantoprazole 40 mg gastro-resistant tablets, PL 45841/0018

Batch No. Expiry Date Pack Size First Distributed
ET571E3001 May 2025 28 18/10/2023
ET571E3002 May 2025 28 26/09/2023
ET571E3003 May 2025 28 13/09/2023
ET571E3004 May 2025 28 13/09/2023
ET571E3005 Jun 2025 28 20/11/2023
ET571E3006 Jun 2025 28 17/01/2024
ET571E3007 Jun 2025 28 19/12/2023
ET571E3008 Jun 2025 28 Not yet distributed

SNOMED Code: 38419011000001108

Active Pharmaceutical Ingredient: Pantoprazole as sodium sesquihydrate

Brief description of the problem

Crescent Pharma Limited has informed the MHRA regarding an error with the European Article Number (EAN) barcode on the cartons of the above-mentioned batches of Pantoprazole 40 mg Gastro-Resistant Tablets distributed by Crescent Pharma Limited. When scanned, the EAN barcode identifies the product as Bicalutamide 150 mg Tablets. The other product details on the carton, including the name, strength and pharmaceutical form of the medicine are correct. The Global Trade Item Number (GTIN) code printed on the pack and included in the 2D falsified medicines directive (FMD) barcode is correct.

Advice for healthcare professionals

Product quality of the Pantoprazole 40 mg Gastro-Resistant Tablets is not impacted by this issue, therefore the affected batches are not being recalled. Healthcare professionals and recipients of this notification are advised not to use these batches of medicine in robotic or automated dispensing or stocking systems and to carry out manual dispensing and stocking, as appropriate.

The manufacturer has confirmed that the batch that has yet to be distributed will be accompanied by a note explaining the issue to supplement dispensing at pharmacies. These batches will not be repackaged to avoid any supply concerns.

Cadila Pharmaceuticals (UK) Limited and Crescent Pharma Limited have confirmed that all future batches of the product will have the correct EAN barcode.

View full alert here.

Advice for patients

No action is needed from patients. The issue is related to the wrong barcode on the cartons of the listed batches of Pantoprazole 40 mg Gastro-Resistant Tablets and will be controlled by the healthcare professional dispensing the medication. The quality of the medication itself is not affected.

Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Further Information

For medical information enquiries please contact pharmacovigilance-eu@cadilapharma.com or telephone: +44 1217901596

For stock control enquiries please contact info@crescentpharma.com or telephone: 01256 772730

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