Class 4 Caution in Use
09.03.2021
Accord-UK Ltd have informed us that important safety warnings for the excipient Propylene glycol are missing from the patient information leaflet (PIL) used in the above batches(including the batches waiting QP certification) which should be present in accordance with the current annex to the Excipient Guidelines. Additionally, the warnings for sorbitol need updating although similar warnings are already present. The product is not subject to recall due to supply and shortage considerations
The affected products' details are as follows:
PIP Code | Product Description | Supplier | Affected Batch |
1059633 | DIAZEPAM SF SOLN 2MG/5ML ACC (100ML) | ACCORD-UK LTD | I54655 I54797 I54798 I55223 I55399 I55506 I55623 I55894 I56131 I56055 I56132 |
1202613 | DIAZEPAM SF SOLN 2MG/5ML ALM (100ML) | ALMUS | I54468 I54799 I55408 I55624 |
Alliance healthcare do not stock this product therefore we are not accepting stock returns.
For more information or medical information queries, please contact:
Accord-UK Ltd Medical Information Department on 01271 385257
For stock control queries, please contact: Accord-UK Ltd Customer Services Team on 0800 373573
Recipients of this Drug Alert should bring it to the attention of relevant contacts.