Adverse Event Report

Report

reporttype2Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID11599122serious1Date Last Updated06/10/2015receiptdateformat102seriousnessdeath1companynumbUS-MYLANLABS-2015M1032731occurcountryUSduplicate1Date Received06/10/2015transmissiondate04/03/2016primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Reaction

1)

reactionmeddraversionpt18.1ReactionCompleted suicideOutcomeFatal

Drug

1)

drugcharacterization1medicinalproductABSORICAdrugstructuredosagenumb80drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext80 MG, QDdrugadministrationroute048drugindicationACNEdrugstartdateformat602drugstartdate//2015drugenddateformat602drugenddate//2015

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberNDA021951Brand NameABSORICAGeneric NameISOTRETINOINManufacturersSun Pharmaceutical Industries, Inc.product_ndc 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 10631-002, 106 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI 197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 154 ... spl_ida8d4793a-5043-40e1-b623-35812733499fspl_set_id3ef0cff8-19c1-4441-b780-fca6c7ee1615Package NDC 10631-115-69, 10631-115-31, 10631-116-69, 10631-116-31, 10631-117-69, 10631-117- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

2)

drugcharacterization2medicinalproductPROBIOTICS /07325001/drugdosagetextUNK

3)

drugcharacterization2medicinalproductCORTISONEdrugdosagetextUNK, PRNdrugadministrationroute061drugindicationACNEdrugstartdateformat602drugstartdate//2015

activesubstance

activesubstancenameCORTISONE\HYDROCORTISONE

openFDA Info on Medication

Application Numberpart348Brand NameCORTISONE PLUS ALOE MAXIMUM STRENGTH, CORTISONEGeneric NameHYDROCORTISONEManufacturersCVS Pharmacyproduct_ndc59779-319, 59779-878Product TypeHUMAN OTC DRUGRouteTOPICALActive IngredientsHYDROCORTISONERXCUI106258, 103403spl_idfad0f9ec-cde0-4e2d-9ba4-477bb5417b31, 6f0c85d8-2fcc-47ee-b864-a394cb49e390spl_set_id6f087a47-36f7-4a9c-aa45-8d174bc3212f, c766deac-d993-4e48-a5c3-4cfde7338dffPackage NDC59779-319-56, 59779-319-16, 59779-878-25NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIWI4X0X7BPJ

4)

drugcharacterization2medicinalproductLORATADINE.drugdosagetextUNK

activesubstance

activesubstancenameLORATADINE

openFDA Info on Medication

Application Number ANDA210722, ANDA076471, ANDA076301, ANDA202538, ANDA076805, ANDA075209, ANDA0757 ... Brand Name LORATADINE, ALLERGY RELIEF, CHILDRENS LORATADINE SUGAR FREE, COUNTERACT ALLERGY, ... Generic NameLORATADINE, LORATADINE ORALManufacturers Granules India Ltd, Geri-Care Pharmaceutical Corp, Shopko Stores Operating Co., ... product_ndc 62207-787, 57896-788, 37012-612, 69452-211, 69842-540, 54473-166, 36800-608, 036 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLORATADINE, FAMOTIDINERXCUI 311372, 828269, 692783, 1087051, 311373, 665078, 744830, 206805, 1020126, 755478 ... spl_id 9aadc2f2-d0ea-5297-e053-2995a90ac51e, 9aa07ca9-ee19-89c7-e053-2a95a90ae9b5, 105d ... spl_set_id 0dee9036-d51f-4d7f-b5e2-4f6940249eef, 41fab408-35cb-47cc-bd4e-bba4ec10f6c7, 47b0 ... Package NDC 62207-787-51, 62207-787-59, 57896-788-03, 57896-788-09, 37012-612-65, 37012-612- ... UNII7AJO3BO7QN, 5QZO15J2Z8NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]

5)

drugcharacterization1medicinalproductAMNESTEEMdrugauthorizationnumb075945drugstructuredosagenumb80drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext80 MG, QDdrugdosageformCAPSULEdrugadministrationroute048drugindicationACNEdrugstartdateformat602drugstartdate//2015drugenddateformat602drugenddate//2015

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA075945Brand NameAMNESTEEMGeneric NameISOTRETINOINManufacturersMylan Pharmaceuticals Inc.product_ndc0378-6611, 0378-6612, 0378-6614Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 404058, 404061, 404064spl_id47bb51b9-0613-4708-905f-e950dbfa5127spl_set_idb2cb63c9-f825-4991-9a2c-6260f1bbcc2cPackage NDC 0378-6611-85, 0378-6611-93, 0378-6612-85, 0378-6612-93, 0378-6614-85, 0378-6614- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

6)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNK

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

7)

drugcharacterization2medicinalproductVITAFUSION CALCIUMdrugdosagetextUNK

8)

drugcharacterization2medicinalproductIBUPROFEN.drugdosagetextUNKdrugrecurreadministration2

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application Number ANDA077349, ANDA206568, ANDA074937, ANDA091355, ANDA075139, ANDA078682, ANDA0791 ... Brand Name CAREONE IBUPROFEN, IBUPROFEN, HEALTH MART CHILDRENS IBUPROFEN, IBUPROFEN MINIS, ... Generic Name IBUPROFEN, IBUPROFEN TABLETS, IBUPROFEN 200MG, IBUPROFEN ORAL, IBUPFROFEN, IBUPR ... Manufacturers American Sales Company, Family Dollar (FAMILY WELLNESS), Strategic Sourcing Serv ... product_ndc 41520-495, 55319-745, 62011-0214, 49738-510, 59779-392, 11822-3307, 50804-199, 7 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsIBUPROFEN, IBUPROFEN SODIUMRXCUI 310965, 310964, 197803, 204442, 310963, 731536, 197805, 197806, 197807, 206905, ... spl_id 0647c7c2-b153-4d8c-b72b-f63d43c41853, 720dc13b-5778-44fa-a4d2-e35db0b2d589, 397d ... spl_set_id 03cdff8a-8890-440d-82b5-54ce809f88cc, 135f910d-a5cd-46e9-9436-015170cc7e38, 1d81 ... Package NDC 41520-495-71, 41520-495-78, 55319-745-30, 55319-745-80, 55319-745-16, 62011-0214 ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, RM1CE97Z4N

9)

drugcharacterization2medicinalproductOSTEO BI-FLEX /01431201/drugdosagetextUNKdrugrecurreadministration3

summary

narrativeincludeclinicalCASE EVENT DATE: 20150920

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2015M1032731

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use