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 Number: S347A
- PI Batch Number: S347A/3153
- Expiry Date: Jan 2018
- Pack Size: 2 x 14
- First Distributed: 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.
Download document
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.