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

 

 



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