Denzapine 50mg/ml Oral Suspension - company led recall

Britannia Pharmaceuticals Ltd has issued a company-led drug alert for Denzapine 50mg/ml Oral Suspension (CLDA (18)A/03)

• From: Medicines and Healthcare products Regulatory Agency
• Published: 25 June 2018

• Message type: Medicines recall/notification
• Issued: 25 June 2018

Product information

CLDA number

CLDA (18)A/03

MDR number

42-05/18

Company name

Britannia Pharmaceuticals Ltd

Product description

Denzapine 50mg/ml Oral Suspension

PL04483/0071

Batch number/expiry

Batch No.	Expiry date
Batch A0515	Exp 06/2018
Batch A1046	Exp 08/2018
Batch A2074	Exp 10/2018

Brief description of the problem

Britannia Pharmaceuticals Ltd is recalling the above batches because of increased crystallisation of the active ingredient which may affect delivery of the full dose. The company is also issuing a letter to Healthcare Professionals reminding them of the shaking instructions given in the Summary of Product Characteristics and Patient information Leaflet.

Letter to Healthcare Professionals - Denzapine 50mg/ml Oral Suspension

Company contact for stock enquiries

Britannia Pharmaceuticals Ltd customer services.

Tel: 01189 209 577

customerservices@britannia-pharm.com

Company contact for medical information

Britannia Pharmaceuticals Ltd Medical Information Service.

Tel: 01483 920 763

Enquiries@medinformation.co.uk

Published 25 June 2018