Questran 4g sachet Powder for Oral Suspension - possible contamination with Enterococcus faecium
- Medicines and Healthcare products Regulatory Agency
- 17 December 2014
- 3 June 2013
- Alert type:
- Drug alert
- Medical specialism:
(Bristol-Myers Squibb Pharmaceuticals Limited) Source of possible contamination is believed to be sucrose used within this formulation of Questran – class 2 action within 48 hours. (EL (13)A/15)
03 June 2013
Class 2 medicines recall
Action within 48 hours
Pharmacy, wholesaler and clinic-level recall
Bristol-Myers Squibb Pharmaceuticals Limited
Questran 4g sachet Powder for Oral Suspension
Colestyramine Powder for Oral Suspension
Bristol-Myers Squibb Pharmaceuticals Limited (BMS) is recalling, as a precautionary measure, all lots of the sucrose containing formulation of Questran (colestyramine) Powder for Oral Suspension, that are within expiry date, due to possible contamination with Enterococcus faecium.
The source of the possible contamination is believed to be the sucrose used within this formulation of Questran.
To date the presence of Enterococcus faecium has not been detected in commercial batches of Questran, and there have been no product complaints or reported adverse health events in connection with this issue.
Please note that Questran Light is unaffected by this recall.
Remaining stocks of any Questran batches should be quarantined and returned to the original supplier for credit.
For medical information enquiries please contact BMS by phone on 0800 731 1736 or by email to firstname.lastname@example.org.
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, general practitioners and community pharmacists for information.
Published: 17 December 2014
Issued: 3 June 2013
Alert type: Drug alert
Medical specialism: Pharmacy