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Class 2 Medicines Recall: Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles), EL (20)A/25

Published On:

9 June 2020

Published In:

Torbay Pharmaceuticals is recalling specific batches of Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles) due to a potentially faulty and incorrectly engaged child-resistant container closure.

MDR number

MDR 115-03/20

Comapny name

Torbay Pharmaceuticals (for Veriton Pharma Ltd)

Product description

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

Active pharmaceutical ingredient: Midazolam

Brief description of the problem

Torbay Pharmaceuticals has informed us 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.

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.

Company contacts for further information

For stock control queries please contact Veriton Pharma Ltd., Telephone +44 (0)1932 690325 or email [email protected]

For any medical information enquires please contact Veriton Pharma Ltd., Telephone +44 (0)1932 690325 or email [email protected]

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

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Class 2 Medicines Recall: Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles), EL (20)A/25

Published 8 June 2020

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