Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-DRREDDYS-USA/USA/14/0043977occurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10722740Date Received20/01/2015transmissiondate21/07/2015serious2Date Last Updated20/01/2015primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionEpistaxisOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionPain in extremityOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductBENZOYL PEROXIDE.drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameBENZOYL PEROXIDE

openFDA Info on Medication

Application Numberpart333DBrand Name PUMICE CLEANSING SCRUB- 2.5% BENZOYL PEROXIDE, UNBLEMISH DUAL INTENSIVE ACNE TRE ... Generic NameBENZOYL PEROXIDEManufacturers Only Yourx, Inc., Rodan & Fields, Walgreens, THE PROACTIV COMPANY LLC, Perrigo N ... product_ndc 70367-004, 14222-2120, 0363-0137, 11410-002, 45802-216, 24470-901, 69748-641, 11 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteTOPICALActive IngredientsBENZOYL PEROXIDERXCUI 845836, 200009, 308685, 308694, 142034, 308693, 308689, 308696, 2048985, 106309, ... spl_id 9cd58ce4-747c-9225-e053-2995a90a501c, c99b4e34-310d-4b9f-a8f9-db6ac489c633, 6ccd ... spl_set_id 270814fa-0109-6262-e054-00144ff8d46c, 27ea743c-e080-487d-adc5-e31176f5b9fc, 42b2 ... Package NDC 70367-004-04, 70367-004-08, 70367-004-75, 14222-2120-1, 0363-0137-11, 11410-002- ... UNIIW9WZN9A0GM

2)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWNdrugauthorizationnumb202099drugadministrationroute065drugindicationACNEdrugstartdateformat102drugstartdate12/06/2014drugenddateformat610drugenddate/09/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameZENATANEGeneric NameISOTRETINOINManufacturersDr. Reddy's Laboratories Limitedproduct_ndc55111-113, 55111-135, 55111-136, 55111-137Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 1373333, 1373335, 1373337, 1605088spl_id1f5178c1-0f6f-824d-d0ee-1b973377ccc6spl_set_id27b3cf26-f22e-5b70-1c24-009933b7c6eePackage NDC 55111-135-79, 55111-135-81, 55111-136-79, 55111-136-81, 55111-137-79, 55111-137- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbUS-DRREDDYS-USA/USA/14/0043977