Torbay Pharmaceuticals recalls two batches of Epistatus (midazolam)
Posted: 18 June 2020 | Victoria Rees (European Pharmaceutical Review) | No comments yet
Due to a potentially faulty and incorrectly engaged child-resistant container closure, Torbay Pharmaceuticals has announced a recall of certain Epistatus (midazolam) batches.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced that 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. The company is recalling two batches, with the numbers 191111C and 200113C.
According to the MHRA, 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.
Healthcare professionals have been advised to stop supplying the above batches of Epistatus immediately and quarantine all remaining stock for return to their supplier using the supplier’s approved process.
More information on the Epistatus recall can be found here.
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Torbay Pharmaceuticals, UK Medicines and Healthcare products Regulatory Agency (MHRA)
