The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class two medicines recall for multi-dose bottles of Epistatus (Midazolam) 10mg/ml oromucosal solution of Torbay Pharmaceuticals.
Torbay Pharmaceuticals has informed the MHRA that the child-resistant container closure for Epistatus 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, MHRA noted in a release.
It should be noted that this product is manufactured as an unlicensed special.
Community pharmacists have been advised to stop supplying the products immediately and quarantine all remaining stock and return it to the supplier.
Product Details
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 |
