Crestor 5mg Tablets Parallel Imported by BR Lewis Pharmaceuticals Ltd (Originator name Provisacor) –rogue blister and carton

Potentially a rogue blister and carton may be present in a batch of Crestor 5mg Tablets Parallel Imported by BR Lewis Pharmaceuticals Ltd (Originator name Provisacor) – Class 4 Caution in Use. (EL (16)A/03)

28 April 2016

Class 4 medicines defect information

Caution in Use

Distribute to Pharmacy Level

EL number

EL (16)A/03

MDR number

MDR 38-04/16

Company name

BR Lewis Pharmaceuticals Ltd

Product description

Crestor (Provisacor) 5mg Tablets

PLPI 08929/0462

Batch number/expiry

Originator Batch No. PI Batch No. Expiry Date Pack Size First Distributed
S347A S347A/3153 Jan 2018 2 x 14 05 Jan 2016

Brief description of the problem

One pack of Parallel Imported Crestor 5mg tablets batch S347A/3153 (originator name Provisacor) has been found to contain a rogue blister of 20mg tablets (batch S348A). The rogue blister was over labelled as 5mg tablets, batch S347A/3153. The second blister in the pack was correct (5mg).

The following packs may remain in pharmacy stock:

  • a further 5mg carton containing a rogue blister of 20mg tablets
  • one 20mg carton, over-labelled as 5mg S347A/3153, containing two blisters of 5mg tablets

Advice for healthcare professionals

Pharmacists are asked to check any remaining stock of Crestor 5mg tablets batch S347A/3153 to ensure that the carton and both blisters are correct.

If a 20mg carton or blister is found, please contact AAH Pharmaceuticals Regulatory Department, email: gb-AAHregulatory@AAH.co.uk; tel 02476 532359 to arrange uplift and credit.

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Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics and community pharmacists.

Crestor (Provisacor) 5mg Tablets

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