Class 2 Medicines Recall: Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles)- Torbay Pharmaceuticals
Class 2 Medicines Recall: Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles)- Torbay Pharmaceuticals
June 8, 2020
Class 2 MHRA medicines recall – Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles) – Torbay Pharmaceuticals
Drug alert number: EL (20)A/25
Date issued: 08 June 2020
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:
Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles) – Torbay Pharmaceuticals
Torbay Pharmaceuticals has informed the MHRA that the child-resistant container closure for Epistatus 10mg/mL Oromucosal Solution (Multi Dose Bottles) may be faulty and incorrectly engaged. The child resistant closure can potentially be removed without unscrewing the cap closure. Removal of an incorrectly engaged cap closure will result in the yellow tamper evident band not being retained on the neck of the bottle. It should be noted that this product is manufactured as an unlicensed special.
Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles) Unlicensed Medicine – MS13079
| Batch number | Expiry date | Pack size | First distributed |
| 191111C | 31/11/2021 | 5mL in 30mL bottle | 20/04/2020 |
| 200113C | 31/01/2022 | 5mL in 30mL bottle | 30/03/2020 |
Advice for healthcare professionals
Healthcare professionals are advised to stop supplying the above products immediately and quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Full drug alert can be viewed here.
Company contacts for further information
For stock control queries please contact Veriton Pharma Ltd., Telephone +44 (0)1932 690325 or email info@veritonpharma.com
For any medical information enquires please contact Veriton Pharma Ltd., Telephone +44 (0)1932 690325 or email info@veritonpharma.com
Posted in: Dispensing & Supply, PSNC News
