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Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning is CPSC recall #20091, announced on March 18, 2020. The CPSC cites the following hazard: This recall involves blister packages of prescription medications Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules from Novartis. Packages of Sandimmune 100 mg contain three blister cards with ten soft gelatin capsules per card and packages of Neoral 100 mg contain five blister cards with six soft gelatin capsules per card. The recalled blister packages have "Novartis," the name of the medication, dosage, NDC, lot number and expiration date on the outer package and on the blister cards. Only 100 mg doses of these medications with the following NDC and lot numbers and expiration dates are included in this recall: Recalled Prescription Drugs NDC Numbers Lot Numbers Expiration Date Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules 0078-0241-15 0078-0241-61 APCA136 APCA339 APCA793 APCC238 09/2020 02/2021 01/2022 07/2022 Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules 0078-0248-15 0078-0248-61 APCA437 APCA979 07/2020 03/2021 The remedy is consumers should immediately secure the product out of the sight and reach of children and contact the firm to request a free child-resistant pouch in which to store the blister package medications. consumers can continue to use the medication as directed. the child-resistant pouches should be used to store these medications until new child-resistant blister packaging is available.. Affected brand: Novartis Pharmaceuticals Corporation.
This recall involves blister packages of prescription medications Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules from Novartis. Packages of Sandimmune 100 mg contain three blister cards with ten soft gelatin capsules per card and packages of Neoral 100 mg contain five blister cards with six soft gelatin capsules per card. The recalled blister packages have "Novartis," the name of the medication, dosage, NDC, lot number and expiration date on the outer package and on the blister cards. Only 100 mg doses of these medications with the following NDC and lot numbers and expiration dates are included in this recall: Recalled Prescription Drugs NDC Numbers Lot Numbers Expiration Date Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules 0078-0241-15 0078-0241-61 APCA136 APCA339 APCA793 APCC238 09/2020 02/2021 01/2022 07/2022 Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules 0078-0248-15 0078-0248-61 APCA437 APCA979 07/2020 03/2021
Affected products
Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages
Recalled brands
Novartis Pharmaceuticals Corporation
Remedy
Consumers should immediately secure the product out of the sight and reach of children and contact the firm to request a free child-resistant pouch in which to store the blister package medications. Consumers can continue to use the medication as directed. The child-resistant pouches should be used to store these medications until new child-resistant blister packaging is available.
Recall date
March 18, 2020
CPSC recall #20091 covers Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning, announced by the U.S. Consumer Product Safety Commission on March 18, 2020. The CPSC cites the following hazard: This recall involves blister packages of prescription medications Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules from Novartis. Packages of Sandimmune 100 mg contain three blister cards with ten soft gelatin capsules per card and packages of Neoral 100 mg contain five blister cards with six soft gelatin capsules per card. The recalled blister packages have "Novartis," the name of the medication, dosage, NDC, lot number and expiration date on the outer package and on the blister cards. Only 100 mg doses of these medications with the following NDC and lot numbers and expiration dates are included in this recall: Recalled Prescription Drugs NDC Numbers Lot Numbers Expiration Date Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules 0078-0241-15 0078-0241-61 APCA136 APCA339 APCA793 APCC238 09/2020 02/2021 01/2022 07/2022 Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules 0078-0248-15 0078-0248-61 APCA437 APCA979 07/2020 03/2021
The CPSC remedy for recall #20091 is consumers should immediately secure the product out of the sight and reach of children and contact the firm to request a free child-resistant pouch in which to store the blister package medications. consumers can continue to use the medication as directed. the child-resistant pouches should be used to store these medications until new child-resistant blister packaging is available.. Consumers should stop using the product and follow the instructions in the official CPSC notice.
If you sell Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning on Shopify, stop selling the affected units immediately, notify customers who purchased them, and consider whether you have a Section 15(b) reporting obligation to the CPSC. RecallDocket helps Shopify merchants identify affected SKUs and prepare the required safety report.
The primary source is the official CPSC notice at https://www.cpsc.gov/Recalls/2020/Novartis-Recalls-100-mg-Sandimmune-and-Neoral-Prescription-Drug-Blister-Packages-Due-to-Failure-to-Meet-ChildResistant-Packaging-Requirement-Risk-of-Poisoning. RecallDocket links to it from this page.
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