[{"RecallID":8767,"RecallNumber":"20091","RecallDate":"2020-03-18T00:00:00","Description":"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","URL":"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","Title":"Novartis Recalls 100 mg Sandimmune and Neoral Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning","ConsumerContact":"Novartis toll-free at 866-629-6182 from 8 a.m. to 8 p.m. ET daily, email at Novartis5060@stericycle.com or online at www.pharma.us.novartis.com and in the top navigation of the page go to the News tab and click on Statements, or visit https://www.pharma.us.novartis.com/news/statements/corrective-action-certain-100-mg-sandimmune-and-neoral-blister-packages-us for more information.","LastPublishDate":"2020-03-18T00:00:00","Products":[{"Name":"Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages","Description":"","Model":"","Type":"","CategoryID":"","NumberOfUnits":"About 73,000"}],"Inconjunctions":[],"Images":[{"URL":"https://www.cpsc.gov/s3fs-public/1776_1.jpeg","Caption":"Recalled Neoral® 100 mg soft gelatin capsules"},{"URL":"https://www.cpsc.gov/s3fs-public/1776_2.jpeg","Caption":"Recalled Sandimmune® 100 mg soft gelatin capsules"}],"Injuries":[{"Name":"None reported."}],"Manufacturers":[],"Retailers":[{"Name":"Clinics and pharmacies nationwide as a prescribed medicine from March 2018 through March 2020, at prices varying based on quantities prescribed, health insurance terms, and other factors.","CompanyID":""}],"Importers":[],"Distributors":[{"Name":"Novartis Pharmaceuticals Corporation, of East Hanover, N.J.","CompanyID":""}],"SoldAtLabel":null,"ManufacturerCountries":[{"Country":"United States"}],"ProductUPCs":[],"Hazards":[{"Name":"The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act (PPPA), posing a risk of poisoning if the contents are swallowed by young children.","HazardType":"","HazardTypeID":""}],"Remedies":[{"Name":"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."}],"RemedyOptions":[{"Option":"New Instructions"},{"Option":"Repair"}]},{"RecallID":8353,"RecallNumber":"18183","RecallDate":"2018-07-06T00:00:00","Description":"This recall involves blister packages of prescription drugs from Novartis and Sandoz. The drugs are packaged with 3 to 10 tablets per blister card. The recalled Novartis prescription blister packages have \"Novartis,\" the name of the drug, dosage, NDC, lot number and expiration date printed on the cartons and the blister cards. The recall includes the following: Recalled Novartis Prescription Drugs NDC Numbers Tablet Strength Carton Configuration Lot Numbers Expiration Date Zofran ODT® 0078-0679-61 0078-0679-19 4 mg 30 count: 3 cards with 10 tablets each 1657088 Dec 2019 Zofran ODT® 0078-0680-61 0078-0680-19 8 mg 30 count: 3 cards with 10 tablets each 1641546 Oct 2019 Entresto® (sacubitril/valsartan) 0078-0659-61 0078-0659-35 24 mg/ 26 mg 100 count: 10 cards with 10 tablets each FX000005 FX000004 FX000003 F0010 F0009 F0007 Apr 2020 Apr 2020 Sep 2019 Nov 2018 Aug 2018 Jul 2018 Entresto® (sacubitril/valsartan) 0078-0777-61 0078-0777-35 49 mg/ 51 mg 100 count: 10 cards with 10 tablets each FX000001 F0006 F0005 F0004 Dec 2019 Oct 2019 Aug 2019 Oct 2018 Entresto® (sacubitril/valsartan) 0078-0696-61 0078-0696-35 97 mg/ 103 mg 100 count: 10 cards with 10 tablets each FX000002 F0007 F0006 F0005 F0004 Mar 2020 Feb 2020 Dec 2019 Dec 2018 Oct 2018 The recalled Sandoz prescription blister packages have \"Sandoz,\" the name of the drug, dosage, NDC and lot number printed on the cartons and the blister cards. Lot numbers are listed at www.us.sandoz.com/patients-customers/product-safety-notices. The recall includes the following: Recalled Sandoz Prescription Drugs Tablet Strength NDC Numbers Carton Configuration Azithromycin Tablets 250 mg 0781-5776-06 0781-5776-69 50 count: 5 cards with 10 tablets each Donepezil ODT Tablets 5 mg 0781-5276-06 0781-5276-64 30 count: 3 cards with 10 tablets each Donepezil ODT Tablets 10 mg 0781-5277-06 0781-5277-64 30 count: 3 cards with 10 tablets each Haloperidol Tablets 0.5 mg 0781-1391-13 100 count: 10 cards with 10 tablets each Haloperidol Tablets 1 mg 0781-1392-13 100 count: 10 cards with 10 tablets each Haloperidol Tablets 2 mg 0781-1393-13 100 count: 10 cards with 10 tablets each Haloperidol Tablets 5 mg 0781-1396-13 100 count: 10 cards with 10 tablets each Haloperidol Tablets 10 mg 0781-1397-13 100 count: 10 cards with 10 tablets each Imipramine HCl Tablets 25 mg 0781-1764-13 100 count: 10 cards with 10 tablets each Imipramine HCl Tablets 50 mg 0781-1766-13 100 count: 10 cards with 10 tablets each Isosorbide Dinitrate (ISDN) Tablets 10 mg 0781-1556-13 100 count: 10 cards with 10 tablets each Isosorbide Dinitrate (ISDN) Tablets 20 mg 0781-1695-13 100 count: 10 cards with 10 tablets each Naratriptan Tablets 2.5 mg 0781-5527-06 0781-5527-37 9 count: 1 card with 9 tablets Ondansetron Tablets 8 mg 0781-1681-33 3 count: 1 card with 3 tablets Ondansetron ODT 4 mg 0781-5238-06 0781-5238-64 30 count: 3 cards with 10 tablets each Ondansetron ODT 8 mg 0781-5239-06 0781-5239-64 30 count: 3 cards with 10 tablets each Ondansetron ODT 8 mg 0781-5239-06 0781-5239-80 10 count: 1 card with 10 tablets Perphenazine Tablets 2 mg 0781-1046-13 100 count: 10 cards with 10 tablets each Perphenazine Tablets 4 mg 0781-1047-13 100 count: 10 cards with 10 tablets each Perphenazine Tablets 8 mg 0781-1048-13 100 count: 10 cards with 10 tablets each Risperidone ODT 0.5 mg 0781-5310-06 0781-5310-08 28 count: 7 cards with 4 tablets each Risperidone ODT 1 mg 0781-5311-06 0781-5311-08 28 count: 7 cards with 4 tablets each Risperidone ODT 2 mg 0781-5312-06 0781-5312-08 28 count: 7 cards with 4 tablets each Risperidone ODT 3 mg 0781-5313-06 0781-5313-08 28 count: 7 cards with 4 tablets each Risperidone ODT 4 mg 0781-5314-06 0781-5314-08 28 count: 7 cards with 4 tablets each","URL":"https://www.cpsc.gov/Recalls/2018/Sandoz-and-Novartis-Recall-Prescription-Drug-Blister-Packages-Due-to-Failure-to-Meet-Child-Resistant-Closure-Requirements","Title":"Sandoz and Novartis Recall Prescription Drug Blister Packages Due to Failure to Meet Child-Resistant Closure Requirements","ConsumerContact":"Sandoz and Novartis toll-free at 888-669-6682 from Monday to Friday, 8 a.m. to 8 p.m. ET and Saturday and Sunday, 9 a.m. to 6 p.m. ET or online at www.us.sandoz.com and click on “Patients and Customers” then “Product Safety Notices,” or at www.pharma.us.novartis.com and click on banner “Novartis recalls select product blister packs.”","LastPublishDate":"2018-07-06T00:00:00","Products":[{"Name":"Blister packages of prescription medication","Description":"","Model":"","Type":"","CategoryID":"","NumberOfUnits":"About 470,000"}],"Inconjunctions":[],"Images":[{"URL":"https://www.cpsc.gov/s3fs-public/Picture1_48.png","Caption":"Donepezil ODT 10 mg"},{"URL":"https://www.cpsc.gov/s3fs-public/Picture2_38.png","Caption":"Naratriptan 2.5 mg tablets"},{"URL":"https://www.cpsc.gov/s3fs-public/Picture3_24.png","Caption":"Ondansetron Tablets 8 mg."},{"URL":"https://www.cpsc.gov/s3fs-public/Picture4_17.png","Caption":"Risperidone ODT 2 mg."},{"URL":"https://www.cpsc.gov/s3fs-public/Picture5_9.png","Caption":"Zofran® ODT 4 mg."}],"Injuries":[{"Name":"The firms have received one report of a child ingesting haloperidol from a blister pack."}],"Manufacturers":[],"Retailers":[{"Name":"Clinics and pharmacies nationwide as a prescribed medicine from September 2016 to June 2018, at prices varying based on quantities prescribed, health insurance terms and other factors.","CompanyID":""}],"Importers":[],"Distributors":[{"Name":"Sandoz Inc., of Princeton, N.J.","CompanyID":""},{"Name":"Novartis Pharmaceuticals Corp., of East Hanover, N.J.","CompanyID":""}],"SoldAtLabel":null,"ManufacturerCountries":[{"Country":"Croatia"},{"Country":"India"},{"Country":"Ireland"},{"Country":"Israel"},{"Country":"Italy"},{"Country":"Singapore"},{"Country":"Spain"},{"Country":"United Kingdom"},{"Country":"United States"}],"ProductUPCs":[],"Hazards":[{"Name":"The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.","HazardType":"","HazardTypeID":""}],"Remedies":[{"Name":"Consumers should immediately secure the blister cards to keep them out of the sight and reach of children and contact Novartis or Sandoz for further instructions. Novartis and Sandoz advise that consumers should continue to use the medication as directed once the blister packages are secured."}],"RemedyOptions":[{"Option":"New Instructions"}]}]