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Recalls and Alerts

Class 4 Caution in Use

09.03.2021

Class 4 Drug Alert Diazepam 2mg/5ml Oral Solution Sugar Free Class type: Class 4 Drug Alert (Caution in use only)

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.