MHRA : Company-led drug alert: Recivit Sublingual Tablets - Grünenthal Limited - CLDA (14)A/19...

Company-led recalls 18 November 2014

CLDA number: CLDA (14)A/19

MDR number: MDR 25-11/14

Company name: Grünenthal Limited

Product description: 

Recivit Sublingual Tablets:
133mcg                    PL 21727/0058
267mcg                    PL 21727/0059
400mcg                    PL 21727/0060
533mcg                    PL 21727/0061
800mcg                    PL 21727/0062

Batch number/ Expiry:

• 133mcg: batch no 14628; exp 30/09/2016
• 267mcg: batch no 14630; exp 31/10/2016
• 400mcg: batch no 14632; exp 31/10/2016
• 533mcg: batch no 15025; exp 31/10/2016
• 800mcg: batch no 14636; exp 30/11/2016

Brief description of problem: 

Due to a manufacturing issue, there is a possibility that blisters from the above batches may contain missing and / or two tablets in a single blister cavity.
We understand that a very small number of packs from the affected batches have been distributed to the UK market.

Company contact for stock enquiries:

UDG customer service
Tel 01773 515171

Company contact for medical information enquiries:

Grünenthal Medical Information
Tel 0870 351 8960
Email: medicalinformationuk@grunenthal.com