Swiss drug major Novartis AG is recalling two lots of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL at the consumer level in the US, the U.S. Food and Drug Administration said.
The recall was initiated after crystal formation was observed in some bottles, which could potentially result in incorrect dosing.
Sandimmune Oral Solution is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used to treat chronic rejection in patients previously treated with other immunosuppressive agents.
The affected drugs were packaged in 50 mL bottles, with lot numbers and expiration dates of FX001500 (expiration date 09/2024) and FX001582 (expiration date 09/2024) NDC 0078-0110-22.
These lots were only distributed to wholesalers across the US, beginning in January 2022 and September 2022, respectively.
According to the agency, crystallization of cyclosporine in Sandimmune Oral Solution is likely to result in non-uniform distribution of the cyclosporine in the product, resulting in under-dosing or over-dosing.
Under-dosing may result in lower exposures and decrease in efficacy which could ultimately lead to graft rejection and graft loss in transplant patients, while over-dosage may manifest itself as cyclosporine toxicity in the long term if over exposure continues.
The issue was identified during an investigation of crystallization in a different lot of Sandimmune Oral Solution. No other Sandimmune formulations are impacted.
Novartis has not received any reports of adverse events related to the recalled product to date.
The company is urging distributors, retailers, and consumers to return the product, and to inform health care providers who have prescribed the drug.
Novartis earlier in September had recalled one lot of its Sandimmune Oral Solution citing the same issue of crystal formation. The affected lot number was FX001691 with expiration date of December 2025.
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