MHRAsafety guidance72% confidence
Class 2 Medicines Recall: Sterling Pharmaceuticals Ltd (specials manufacturer MS 32515), KidNaps (Melatonin) 1mg in 1ml Oral Solution, EL(26)A/09
Source: MHRA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (hypophosphatasia) as Efzimfotase alfa shows positive Phase III results in hypophosphatasia.
Regulatory Analysis
Sterling Pharmaceuticals Ltd and Veriton Pharma Ltd are recalling all batches of KidNaps (Melatonin) 1mg in 1ml Oral Solution due to out of specification stability results.
Supporting Context
- Therapeutic area
- Rare Diseases · Hypophosphatasia
- Sub-indication
- Hypophosphatasia
Related signal: Efzimfotase alfa shows positive Phase III results in hypophosphatasia