WASHINGTON, D.C. — Novartis Pharmaceuticals Corporation (Novartis), working in conjunction with the U.S. Consumer Product Safety Commission (CPSC), has implemented a corrective action plan for Novartis’ drug Sandimmune (cyclosporine capsules, USP) 100-mg gel caps, and Neoral (cyclosporine capsules, USP) Modified 100-mg soft gel caps sold in 30-count blister packs sold in the United States that are still within the expiration dates. In a press release, Novartis said that the corrective action plan it started is not due to a quality problem or is deficient in any way. The company launched the corrective action plan because the blister packs in which the medication was packaged was not child-resistant.
Novartis said that any patient who has the recalled medication should contact the company at its toll-free telephone number of email Novartis5060@stericycle.com to claim a resealable child-resistant pouch, without charge, in which the medication could be stored. All instructions required to use the child-resistant pouch will be posted on the pouch for ease of reference.
Novartis reminds patients that they must secure this medication beyond the reach of children and out of their sight immediately to prevent accidental overdose. The risk of harm to a child is significant if a child can open the package and eat the drug. Novartis said that the drugs recalled remain potent, and, therefore, patients must continue taking the drugs as directed by their physician.
Novartis claimed that the CPCS approved this corrective action plan. The steps taken by Novartis to mitigate the potential harm to children that could occur requires the pharmaceutical giant to contact patients, pharmacists, wholesalers, and retailers of the medications to ensure all stakeholders become aware of the possible problem and the proposed solution.
According to Novartis’ recall press release, the Sandimmune under recall will expire in either September 2020, February 2021, January, and July of 2022. The Neoral subject to recall has expiration dates of July 2020 and March of 2021.
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