Dear Customer
Dawa Limited has issued a Class 4 Medicines Defect Information – Caution in Use. In relation to:
Trazodone Hydrochloride 50mg Capsules, PL 30684/0250
Trazodone Hydrochloride 100mg Capsules, PL 30684/0251
Trazodone Hydrochloride 50mg/5ml Oral Solution, PL 30684/0268
Brief description of the problem
Dawa Limited has informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Trazodone Hydrochloride 50mg and 100mg Capsules and Trazodone Hydrochloride 50mg/5ml Oral Solution.
The PIL does not contain the latest safety information relating to serotonergic products (trazodone) and the interaction with buprenorphine.
The following details the affected products & batches that have been stocked, sold & continue to be sold by NVS
| NVS Product Code(s) | Product Description | Affected Batch No’s | Expiry Date | Stock Position |
|---|---|---|---|---|
| 563006 | Trazodone Caps 50mg, PK 84 | 220191 | Apr-26 | Sold Through |
| 220192 | Apr-26 | Sold Through | ||
| 220193 | Apr-26 | Currently Selling | ||
| 220212 | Apr-26 | Sold Through | ||
| 220340 | Jun-26 | Sold Through | ||
| 220382 | Jul-26 | Sold Through |
| NVS Product Code(s) | Product Description | Affected Batch No’s | Expiry Date | Stock Position |
|---|---|---|---|---|
| 578101 | Trazodone Caps 100mg, PK 56 | 200284 | Sept-24 | Sold Through |
| 220213 | May-26 | Sold Through | ||
| 220215 | May-26 | Sold Through | ||
| 220341 | Jun-26 | Currently Selling |
Advice for healthcare professionals
There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the products and where possible, provide an updated PIL.
What to do next – Please read the attached notification letter (Please click here) and bring the issue to the attention of all relevant colleagues within your business. The updated PIL is available electronically and can be downloaded from the links within the notification letter:
