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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