What we know
Summary Date Recall was issued:Product Name:Manufacturer:Recalling Firm:Batch(es):Manufacturing Date:Expiry Date:Reason for Recall: 31st May 2024Ryverna 10mg/ml solution (Crizanlizumab)Novartis, SwitzerlandErnest Chemist Ltd/ NovartisSKHL207/202230/06/2024This recall was necessitated following the revocation of the Market Authorization for Ryverna (Crizanlizumab) from the Ghanaian market which was granted a one-year approval on 16th November 2023. This is because of the unfavourable Benefit/Risk assessment of your product from the clinical trial study “Phase III, Multipurpose, Randomized, Double-Blind Study to Assess Efficacy and Safety of Two Doses of Crizanlizumab Verses Placebo with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Vaso Occlusive Crises (STAND)”. AnnouncementThis recall is necessitated as a result of warehouse market surveillance conducted at the warehouse. Actual product specification is a powder for oral suspension. The affected batches were caked and not free flowing. This makes the product substandard and therefore not recommended for its intended use.
Safety advice
- Stop using or purchasing the product if the notice asks you to.
- Keep receipts, batch numbers and packaging — they help with returns or investigations.
- Share this alert with anyone who might be affected, especially relatives and colleagues.
- If you believe you’ve been harmed, contact the official source or a relevant authority.
