Novartis recalls Sandimmune and Neoral over risk of poisoning
Posted: 23 March 2020 | Hannah Balfour (European Pharmaceutical Review) | No comments yet
The company is recalling 100mg blister packages of both Sandimmune and Neoral due to their packaging not being child-resistant, a fault that could result in infants being poisoned.
Novartis Pharmaceuticals Corporation is recalling blister packages of Sandimmune® (cyclosporine capsules, USP) 100mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100mg soft gelatin capsules due to the packaging not being child-resistant.
At present, neither the company nor the US Consumer Product Safety Commission have received reports of adverse events due to this fault. However, the packaging is required to be child-resistant by the Poison Prevention Packaging Act (PPPA), because the medicine poses a risk of poisoning if the contents are swallowed by young children.
The company expects 73,000 units to be recalled. The drugs were sold as prescription medicines between March 2018 and 2020. Information about the affected lot numbers is listed below:
Recalled Prescription Drugs | NDC Numbers | Lot Numbers | Expiration Date |
Sandimmune (cyclosporine capsules, USP) 100mg soft gelatin capsules | 0078-0241-15 0078-0241-61 | APCA136 APCA339 APCA793 APCC238 | 09/2020 02/2021 or 01/2022 07/2022 |
Neoral (cyclosporine capsules, USP) MODIFIED 100mg soft gelatin capsules | 0078-0248-15 0078-0248-61 | APCA437 APCA979 | 07/2020 03/2021 |
According to the company, consumers with this medication must secure it out of the reach of children and can contact the firm to request a free child-resistant pouch in which to store the packages until they have finished it or new child-resistant blister packaging is available.
Related topics
Drug Safety, Packaging, QA/QC, Regulation & Legislation, Therapeutics
