MHRA: Continue taking 'fishy'-smelling tablets
The medicines watchdog says it has received reports that batches of sodium valproate tablets smell of cannabis and "sweaty armpits"
The MHRA has advised patients to continue taking gastro-resistant tablets despite some batches emitting a “fishy” odour.
An investigation by manufacturer Sanofi had revealed that the smell, which has also been likened to cannabis and “sweaty armpits”, is a result of the aluminium foil used in the packaging, the medicines watchdog said yesterday (March 30).
The MHRA stressed that it had no concerns about the quality or effectiveness of these tablets and Sanofi had now stopped using this foil supplier.
To avoid product shortages, the affected batches had not been recalled and patients should be advised to continue taking their medication, the MHRA said.
Further batches packed in the same foil may have to be distributed to keep the market supplied before tablets packed in foil from an alternative supplier became available at the end of April, it added.
All inquiries should be directed to Sanofi Medical Information at 0845 3727101 or [email protected].
The affected batches are:
Aventis Pharma Limited
Epilim 200mg gastro-resistant tablets, PL 04425/0302, Sanofi livery
|
Batch number |
Expiry date |
Pack size |
First distributed |
|
J601 |
August 2016 |
1 x 100 |
October 23, 2014 |
|
J602 |
August 2016 |
1 x 100 |
November 12, 2014 |
|
J603 |
August 2016 |
1 x 100 |
December 3, 2014 |
|
K1 |
June 2017 |
1 x 100 |
December 29, 2014 |
|
K2 |
September 2017 |
1 x 100 |
January 9, 2015 |
|
K3 |
September 2017 |
1 x 100 |
February 6, 2015 |
|
K7 |
September 2017 |
1 x 100 |
January 5, 2015 |
Epilim 500mg gastro-resistant tablets, PL 04425/0303, Sanofi livery
|
Batch number |
Expiry date |
Pack size |
First distributed |
|
J602 |
August 2016 |
1 x 100 |
December 19, 2014 |
|
J603 |
August 2016 |
1 x 100 |
January 6, 2015 |
|
K1 |
June 2017 |
1 x 100 |
January 22, 2015 |
|
K2 |
June 2017 |
1 x 100 |
February 6, 2015 |
Winthrop Pharmaceuticals UK Limited
Sodium valproate zentiva 200mg gastro-resistant tablets, PL 17780/0453, Zentiva livery
|
Batch number |
Expiry date |
Pack size |
First distributed |
|
K1 |
June 2017 |
1 x 100 |
October 2, 2014 |
Sodium valproate zentiva 500mg gastro-resistant tablets, PL 17780/0454, Zentiva livery
|
Batch number |
Expiry date |
Pack size |
First distributed |
|
J601 |
August 2016 |
1 x 100 |
October 1, 2014 |
