RSDL

Description of Event or Problem

RSDL BATCH FAILED TO MEET SPECIFICATIONS [OUT OF SPECIFICATION TEST RESULTS] CASE NARRATIVE: THIS INITIAL CASE WAS IDENTIFIED ON 10MAR2025 BY A COMPANY REPRESENTATIVE REGARDING THE RSDL (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME; LOT NUMBER: 23002949; MANUFACTURING DATE: 10OCT2019 EXPIRY DATE: 09OCT2024). IT WAS REPORTED THAT "RSDL BATCH 23002949 (57 MONTHS / 25-DEGREE CELSIUS / 60 PERCENT RH) FAILED TO MEET SPECIFICATIONS" (PT: OUT OF SPECIFICATION TEST RESULTS) (DEVIATION-(B)(4)). (B)(4) WAS REPORTED REGARDING RSDL BATCH 23002949 (SKU - F5402G- 21ML US DOD PRODUCT) REACTIVE SKIN DECONTAMINATION LOTION (RSDL) (57 MONTH / 25 DEGREE CELSIUS / 60 PERCENT RH) FAILED TO MEET SPECIFICATION FOR THE DETERMINATION OF POTASSIUM 2,3-BUTANEDIONE MONOXIMATE (KBDO) CONTENT AND DIACETYL MONOXIME (DAM) CONTENT IN REACTIVE SKIN DECONTAMINATION LOTION (RSDL) AT THE 57-MONTH TIME POINT OR END OF SHELF LIFE 21ML FINISHED PRODUCT CONFIGURATION. THE INCIDENT DID NOT OCCUR DURING USE. THE EVENT EFFECTS ONLY ONE MANUFACTURING RUN FOR A CUSTOMER IN THE UNITED STATES (US). THE INITIAL INVESTIGATION INDICATES THAT THIS FAILURE WAS RESTRICTED TO RSDL 21ML FINISHED GOOD BATCH 23002949. ANOTHER BATCH (FG23002943) ON STABILITY WITH THE SAME KBDO AND DAM BULK COMPONENTS AS BATCH 23002949 HAS MET SPECIFICATIONS FOR KBDO AND DAM THROUGHOUT THE SHELF LIFE. ADDITIONALLY ANNUAL STABILITY BATCHES IN 2019 AND 2021 AS WELL AS ANOTHER BATCH ON STABILITY FROM 2020 ARE ALL MEETING KBDO AND DAM SPECIFICATIONS. ON (B)(6) 2024, A PHASE I INVESTIGATION (PU-24-00127) WAS GENERATED IN THE LABVANTAGE LABORATORY INFORMATION MANAGEMENT SYSTEM (LV LIMS) FOR THE DAM AND KBDO RESULTS. THE 57-MONTH TIMEPOINT FOR BATCH 23002949 MATERIAL NUMBER (M/N) MNF5402G (25C/60 PERCENT RH) WAS TESTED AS PER PROCEDURES FOR DAM AND KBDO AND PRODUCED A RESULT OF 1.23 WEIGHT PERCENT FOR DAM AND 13.1 WEIGHT PERCENT FOR KBDO. SPECIFICATION FOR DAM IS 0.78 WEIGHT PERCENT - 1.20 WEIGHT PERCENT AND FOR KBDO IS 13.3 WEIGHT PERCENT -16.2 WEIGHT PERCENT. THIS IS A DEVIATION FROM (B)(4) V12.0 FINAL DEVICE STABILITY FOR RSDL. THE ASSESSMENT SUMMARY (A-12-24-0380) CONFIRMED THERE WAS NO CONFIRMED LABORATORY ERROR IN EXECUTION OF THE ASSAY AS PER TMD024698 AND IDENTIFIED THAT HYPOTHESIS TESTING WAS REQUIRED TO DETERMINE IF THE STORAGE CONDITIONS OF THE SAMPLE CONTRIBUTED TO THE OOS RESULTS. ON 14JAN2025, HYPOTHESIS TESTING WAS APPROVED UNDER H-01-25-0413. THE HYPOTHESIS WAS THAT THE STORAGE CONDITIONS OF THE SAMPLE CONTRIBUTED TO THE OUT-OF-SPECIFICATION (OOS) RESULT. THIS STUDY ASSESSED THE STABILITY OF ALIQUOTED RSDL SAMPLES OVER THE COURSE OF 5 WEEKS, AS PER TESTING PROTOCOL. THE STUDY INCLUDED FOUR DIFFERENT STORAGE CONDITIONS WHICH REPRESENT THE PERFECT STORAGE CONDITIONS (IN A GLOVEBOX), CURRENT PRACTICE AND WORST-CASE CONDITIONS TO DETERMINE IF THERE IS A CHANGE IN DAM AND KBDO REPORTABLE VALUES OVER THE COURSE OF 30 DAYS, I.E., THE PERIOD IN WHICH STABILITY SAMPLES MAY BE HELD. A. PERFECT CONDITIONS: 3 ML OF RSDL IN A SMALL AMBER VIAL STORED UNDER NITROGEN IN A GLOVE BOX. B. NORMAL CONDITIONS (AS PER PROCEDURE): 3 ML OF RSDL IN A SMALL AMBER VIAL, MANUALLY PURGED WITH NITROGEN, CAPPED THEN WRAPPED WITH PARAFILM, STORED IN THE RSDL SAMPLE STORAGE AREA IN ROOM A180. C. POOR CONDITIONS: 3 ML OF RSDL IN A SMALL AMBER VIAL, WITHOUT A NITROGEN PURGE, STORED IN THE RSDL SAMPLE STORAGE AREA IN ROOM A180. D. WORST-CASE CONDITIONS: 1 ML OF RSDL IN A LARGE AMBER VIAL (TO MAXIMIZE SURFACE AREA EXPOSURE), WITHOUT A NITROGEN PURGE STORED IN THE RSDL SAMPLE STORAGE AREA IN ROOM A180. THE PROTOCOL TEST RESULTS WERE REVIEWED TO DETERMINE IF THERE IS EVIDENCE OF SAMPLE DEGRADATION OVER THE SPAN OF 30 DAYS IN ANY OF THE SAMPLE STORAGE CONDITIONS. THE STUDY DEMONSTRATED THAT RSDL FINISHED PRODUCT SAMPLES ALIQUOTED INTO AMBER GLASS VIALS AND STORED UNDER NITROGEN DID NOT SHOW A STATISTICALLY SIGNIFICANT CHANGE IN DAM OR KBDO REPORTABLE VALUES OVER 34 DAYS. THE RSDL FINISHED PRODUCT SAMPLES ALIQUOTED INTO AMBER GLASS VIALS AND STORED UNDER NORMAL ATMOSPHERE DID SHOW A SMALL BUT STATISTICALLY SIGNIFICANT CHANGE IN DAM AND KBDO REPORTABLE VALUES OVER 34 DAYS. WHILE THIS STUDY CONFIRMED THAT SAMPLE ALIQUOT STORAGE CONDITIONS ARE IMPORTANT TO SAMPLE INTEGRITY, IT DID NOT CONFIRM THAT A LAB ERROR OCCURRED WITH RESPECT TO SAMPLE HANDLING AND STORAGE. THEREFORE, THIS INVESTIGATION PROCEEDS TO PHASE II WHICH IS ONGOING AT THIS TIME. THE OUTCOME OF THE REPORTED EVENT WAS NOT APPLICABLE, THERE WAS NO PATIENT OR CONSUMER EXPOSURE. ACTION TAKEN WITH RSDL WITH RESPECT TO THE REPORTED EVENT WAS NOT APPLICABLE. NO FURTHER INFORMATION WAS PROVIDED. ON 10MAR2025, THE INVESTIGATION ASSOCIATED WITH THIS RSDL PRODUCT QUALITY COMPLAINT WAS COMPLETED AND THE FINAL COMPLAINT REPORT WAS RETRIEVED ON 14MAY2025. THE INVESTIGATION NOTED DEVIATION AS CRITICAL AND THE ROOT CAUSE OF OUT OF SPECIFICATION TEST RESULTS WAS UNDETERMINED/INCONCLUSIVE, AND NO CORRECTIVE ACTIONS WERE INITIATED TO REDUCE OR ELIMINATE THE ROOT CAUSE FOR THIS DEVIATION. ON 29OCT2024, RSDL MATERIAL NUMBER (MN) F5402G BATCH 23002949 (57 MONTH / 25 DEGREE CELSIUS / 60 PERCENT RH STABILITY) WAS TESTED AS PER TMD024698 V14.0 DETERMINATION OF POTASSIUM 2,3-BUTANEDIONE MONOXIMATE (KBDO) CONTENT AND DIACETYL MONOXIME (DAM) CONTENT IN REACTIVE SKIN DECONTAMINATION LOTION (RSDL); SAMPLE RESULTS WERE 1.23 WT PERCENT FOR DAM AND 13.1 WT PERCENT FOR KBDO. THESE RESULTS DO NOT MEET THE REQUIREMENTS OF (B)(4) V12.0 FINAL DEVICE STABILITY FOR RSDL; SPECIFICATIONS ARE 0.78-1.20 WT PERCENT FOR DAM AND 13.3-16.2 WT PERCENT FOR KBDO. ON (B)(6) 2024, A PHASE I INVESTIGATION WAS GENERATED IN THE LABVANTAGE LABORATORY INFORMATION MANAGEMENT SYSTEM (LV LIMS) AS PER (B)(4) V2.0 GLOBAL SOP FOR LAB INVESTIGATIONS. THE ASSESSMENT SUMMARY CONFIRMED THERE WAS NO CONFIRMED LABORATORY ERROR IN EXECUTION OF THE ASSAY AS PER TMD024698 AND IDENTIFIED THAT HYPOTHESIS TESTING WAS REQUIRED TO DETERMINE IF THE STORAGE CONDITIONS OF THE SAMPLE CONTRIBUTED TO THE OOS RESULTS. ON 04JAN2024, THE HYPOTHESIS TEST PLAN WAS APPROVED TO INVESTIGATE IF THE STORAGE CONDITIONS OF THE SAMPLE CONTRIBUTED TO THE OUT-OF-SPECIFICATION (OOS) RESULT. PRO055834 V1.0 ASSESSMENT OF STORAGE CONDITIONS FOR RSDL STABILITY SAMPLE ALIQUOTS ASSESSED THE STABILITY OF ALIQUOTED RSDL SAMPLES OVER THE COURSE OF FIVE WEEKS. PRO055834 DID CONFIRM THAT SAMPLE ALIQUOTS ARE STABLE FOR AT LEAST 34 DAYS WHEN STORED PROPERLY (I.E., UNDER INERT HEADSPACE). THIS STUDY ALSO DEMONSTRATED THAT IF SAMPLES ARE NOT STORED WITH AN INERT HEADSPACE, A STATISTICALLY RELEVANT CHANGE IN RESULTS IS OBSERVED WITHIN A 34-DAY WINDOW. HOWEVER, IT CANNOT BE CONFIRMED WHETHER THE INERT HEADSPACE WAS APPLIED TO THE SAMPLE ALIQUOTS IN QUESTION. THEREFORE, AS PER (B)(4) V3.0 GLOBAL SOP FOR LAB INVESTIGATIONS, THIS INVESTIGATION PROCEEDS TO PHASE II. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE IS UNDETERMINED / INCONCLUSIVE. RETEST RESULTS DID NOT MEET SPECIFICATION; MN F5402G BATCH 23002949 HAS BEEN CONFIRMED OOS AT 57 MONTHS / 25-DEGREE CELSIUS/ 60 PERCENT RH (END-OF-LIFE). MN 4002001 BATCH 23002943, MANUFACTURED WITH THE SAME BULK PRODUCT AND ALSO PLACED ON STABILITY, MET REQUIREMENTS AT 57 MONTHS / 25-DEGREE CELSIUS/ 60 PERCENT RH (END-OF-LIFE). THE OOS HAS IMPACT ON THE FINISHED GOOD (FG) BATCH 23002949, HOWEVER IT HAD NO IMPACT TO THE OTHER THREE FG BATCHES (23002943, 23002842 AND 23002816) MANUFACTURED FROM THE SAME BULK PRODUCT BATCH 21001341 BECAUSE THE CAUSE OF THE OOS WAS NOT DETERMINED TO BE RELATED TO THE BULK AND THERE WERE NO OOS RESULTS FOR THE OTHER FG BATCHES. THE FINISHED GOOD BATCH RECORDS FOR 23002949 (IMPACTED LOT), 23002943, 23002842 AND 23002816 WERE REVIEWED. THE REVIEW DID NOT FIND ANY DEVIATIONS OR INVESTIGATIONS RELATED TO THESE BATCHES. THE BATCH RECORDS AND QC TEST ANALYSIS CONFORMED TO THE REQUIREMENTS FOR THESE FOUR FG BATCHES. FG LOTS 23002949, 23002842 AND 23002816 WERE 21 ML DEVICES. FG LOT 23002949 WAS THE LAST ASSEMBLED 21 ML DEVICE, BUT IT WAS WITHIN THE QUALIFIED HOLD TIME FOR BULK RSDL OF 120 DAYS (AS PER RPT043136). FG LOT 23002943 WAS THE 42 ML DEVICE CONFIGURATION. THERE WERE NO RELEVANT DEFECTS OBSERVED DURING THE QC OVER INSPECTION OF FG LOT 23002949. THE BULK RELEASE TESTING AND STABILITY TIME ZERO TEST RESULTS ALL MET REQUIREMENTS. EXCLUDING THE INITIAL OOS TEST RESULT AT 48 MONTHS (I.E. CONSIDERING ONLY THE 48-MONTH RETEST RESULTS; DEV-008510), THE STABILITY TRENDS FOR DAM AND KBDO IN BATCH 23002949 PRIOR TO THE FINAL 57-MONTH TIME POINT ARE ALIGNED WITH THE OTHER FINAL DEVICE STABILITY LOTS FILLED FROM RSDL BULKS MANUFACTURED AT A TARGET DAM CONCENTRATION OF 0.84 WT PERCENT. SINCE THE ROOT CAUSE REMAINS UNDETERMINED, THERE ARE NO CORRECTIVE OR PREVENTIVE ACTIONS TO COMPLETE THROUGH THIS INVESTIGATION. THERE IS NO EFFECTIVENESS CHECK REQUIRED PER (B)(4) V5.0 GLOBAL GXP CAPA MANAGEMENT AS NO CORRECTIVE ACTIONS WERE INITIATED TO REDUCE OR ELIMINATE THE ROOT CAUSE FOR THIS DEVIATION. ON 31MAR2025, SP (QA COMPLIANCE SPECIALIST I) CONFIRMED THAT THERE ARE NO COMPLAINTS RELATED TO RSDL BATCH 23002949. ON 07APR2025, THE EMERGENT PHARMACOVIGILANCE TEAM CONFIRMED THAT THERE ARE NO ADVERSE EVENTS RELATED TO RSDL BATCH 23002949. COMPANY COMMENT: THIS CASE WAS RECEIVED ON 10MAR2025, FROM A COMPANY REPRESENTATIVE REGARDING THE RSDL DEVICE (DEKON 139, CONTAINING METHOXYPOLYETHYLENE GLYCOL 550 AND 2,3-BUTANEDIONE MONOXIME; LOT NUMBER: 23002949; EXPIRY DATE: 09OCT2024). IT WAS REPORTED THAT "RSDL BATCH 23002949 (57 MONTHS / 25-DEGREE CELSIUS/ 60 PERCENT RH) FAILED TO MEET STABILITY SPECIFICATIONS FOR THE DETERMINATION OF POTASSIUM 2,3-BUTANEDIONE MONOXIMATE (KBDO) CONTENT AND DIACETYL MONOXIME (DAM) CONTENT IN REACTIVE SKIN DECONTAMINATION LOTION (RSDL) AT THE 57-MONTH TIME POINT OR END OF SHELF LIFE. IT SHOULD BE NOTED THAT AT THE 48-MONTH STABILITY TIME POINT (JAN-2024) AN OOS INVESTIGATION WAS CONDUCTED FOR DAM AND KBDO OF THE SAME BATCH. HOWEVER, RETEST RESULTS DID NOT CONFIRM THE ORIGINAL OOS RESULT, WITH ¿METHOD¿ CONSIDERED THE PROBABLE ROOT CAUSE. THE EVENT OF OUT OF SPECIFICATION TEST RESULTS IS CONSIDERED AS SERIOUS (OTHER- MALFUNCTION). THE CAUSALITY OF OUT OF SPECIFICATION TEST RESULTS HAS BEEN ASSESSED AS NOT RELATED TO RSDL, OR TO THE USE OF RSDL. RSDL IS USED TO NEUTRALIZE OR REMOVE CHEMICAL AGENTS OR T2 TOXINS FROM THE SKIN. WHILE THIS ISSUE MAY AFFECT THE PRODUCT'S EFFICACY, IT WAS NOT ASSOCIATED WITH ANY ADVERSE EVENTS (AE). THERE IS A POTENTIAL RISK THAT THE PRODUCT MAY BE LESS EFFECTIVE IF EXPOSED TO A CHEMICAL AGENT, WHICH COULD POTENTIALLY LEAD TO SERIOUS INJURY OR DEATH IF IT WERE TO RECUR. HOWEVER, NO ADVERSE EVENTS WERE REPORTED, AND THE PRODUCT HAS SINCE EXPIRED. DESPITE THOROUGH ASSESSMENTS, INCLUDING INVESTIGATIONS THE ROOT CAUSE IS UNDETERMINED / INCONCLUSIVE. CASE COMMENTS: NA.

Description of Event or Problem

RSDL BATCH FAILED TO MEET SPECIFICATIONS [OUT OF SPECIFICATION TEST RESULTS] CASE NARRATIVE: THIS INITIAL CASE WAS IDENTIFIED ON 10 MAR 2025 BY A COMPANY REPRESENTATIVE REGARDING THE RSDL (DEKON 139, METHOXYPOLYETHYLENE GLYCOL 550, 2,3 BUTANEDIONE MONOXIME; LOT NUMBER: 23002949; MANUFACTURING DATE: 10OCT2019 EXPIRY DATE: 09OCT2024). IT WAS REPORTED THAT "RSDL BATCH 23002949 (57 MONTHS / 25-DEGREE CELSIUS / 60 PERCENT RH) FAILED TO MEET SPECIFICATIONS" (PT: OUT OF SPECIFICATION TEST RESULTS) (DEVIATION-010587). DEVIATION-010587 WAS REPORTED REGARDING RSDL BATCH 23002949 (SKU - F5402G- 21ML US DOD PRODUCT) REACTIVE SKIN DECONTAMINATION LOTION (RSDL) (57 MONTH / 25 DEGREE CELSIUS / 60 PERCENT RH) FAILED TO MEET SPECIFICATION FOR THE DETERMINATION OF POTASSIUM 2,3-BUTANEDIONE MONOXIMATE (KBDO) CONTENT AND DIACETYL MONOXIME (DAM) CONTENT IN REACTIVE SKIN DECONTAMINATION LOTION (RSDL) AT THE 57-MONTH TIME POINT OR END OF SHELF LIFE 21ML FINISHED PRODUCT CONFIGURATION. THE INCIDENT DID NOT OCCUR DURING USE. THE EVENT EFFECTS ONLY ONE MANUFACTURING RUN FOR A CUSTOMER IN THE UNITED STATES (US). THE INITIAL INVESTIGATION INDICATES THAT THIS FAILURE WAS RESTRICTED TO RSDL 21ML FINISHED GOOD BATCH 23002949. ANOTHER BATCH (FG23002943) ON STABILITY WITH THE SAME KBDO AND DAM BULK COMPONENTS AS BATCH 23002949 HAS MET SPECIFICATIONS FOR KBDO AND DAM THROUGHOUT THE SHELF LIFE. ADDITIONALLY ANNUAL STABILITY BATCHES IN 2019 AND 2021 AS WELL AS ANOTHER BATCH ON STABILITY FROM 2020 ARE ALL MEETING KBDO AND DAM SPECIFICATIONS. ON 04NOV2024, A PHASE I INVESTIGATION (PU-24-00127) WAS GENERATED IN THE LABVANTAGE LABORATORY INFORMATION MANAGEMENT SYSTEM (LV LIMS) FOR THE DAM AND KBDO RESULTS. THE 57-MONTH TIMEPOINT FOR BATCH 23002949 MATERIAL NUMBER (M/N) MNF5402G (25C/60 PERCENT RH) WAS TESTED AS PER PROCEDURES FOR DAM AND KBDO AND PRODUCED A RESULT OF 1.23 WEIGHT PERCENT FOR DAM AND 13.1 WEIGHT PERCENT FOR KBDO. SPECIFICATION FOR DAM IS 0.78 WEIGHT PERCENT - 1.20 WEIGHT PERCENT AND FOR KBDO IS 13.3 WEIGHT PERCENT -16.2 WEIGHT PERCENT. THIS IS A DEVIATION FROM SPE002591 V12.0 FINAL DEVICE STABILITY FOR RSDL. THE ASSESSMENT SUMMARY (A-12-24-0380) CONFIRMED THERE WAS NO CONFIRMED LABORATORY ERROR IN EXECUTION OF THE ASSAY AS PER TMD024698 AND IDENTIFIED THAT HYPOTHESIS TESTING WAS REQUIRED TO DETERMINE IF THE STORAGE CONDITIONS OF THE SAMPLE CONTRIBUTED TO THE OOS RESULTS. ON 14JAN2025, HYPOTHESIS TESTING WAS APPROVED UNDER H-01-25-0413. THE HYPOTHESIS WAS THAT THE STORAGE CONDITIONS OF THE SAMPLE CONTRIBUTED TO THE OUT-OF-SPECIFICATION (OOS) RESULT. THIS STUDY ASSESSED THE STABILITY OF ALIQUOTED RSDL SAMPLES OVER THE COURSE OF 5 WEEKS, AS PER TESTING PROTOCOL. THE STUDY INCLUDED FOUR DIFFERENT STORAGE CONDITIONS WHICH REPRESENT THE PERFECT STORAGE CONDITIONS (IN A GLOVEBOX), CURRENT PRACTICE AND WORST-CASE CONDITIONS TO DETERMINE IF THERE IS A CHANGE IN DAM AND KBDO REPORTABLE VALUES OVER THE COURSE OF 30 DAYS, I.E., THE PERIOD IN WHICH STABILITY SAMPLES MAY BE HELD. A. PERFECT CONDITIONS: 3 ML OF RSDL IN A SMALL AMBER VIAL STORED UNDER NITROGEN IN A GLOVE BOX. B. NORMAL CONDITIONS (AS PER PROCEDURE): 3 ML OF RSDL IN A SMALL AMBER VIAL, MANUALLY PURGED WITH NITROGEN, CAPPED THEN WRAPPED WITH PARAFILM, STORED IN THE RSDL SAMPLE STORAGE AREA IN ROOM A180. C. POOR CONDITIONS: 3 ML OF RSDL IN A SMALL AMBER VIAL, WITHOUT A NITROGEN PURGE, STORED IN THE RSDL SAMPLE STORAGE AREA IN ROOM A180. D. WORST-CASE CONDITIONS: 1 ML OF RSDL IN A LARGE AMBER VIAL (TO MAXIMIZE SURFACE AREA EXPOSURE), WITHOUT A NITROGEN PURGE STORED IN THE RSDL SAMPLE STORAGE AREA IN ROOM A180. THE PROTOCOL TEST RESULTS WERE REVIEWED TO DETERMINE IF THERE IS EVIDENCE OF SAMPLE DEGRADATION OVER THE SPAN OF 30 DAYS IN ANY OF THE SAMPLE STORAGE CONDITIONS. THE STUDY DEMONSTRATED THAT RSDL FINISHED PRODUCT SAMPLES ALIQUOTED INTO AMBER GLASS VIALS AND STORED UNDER NITROGEN DID NOT SHOW A STATISTICALLY SIGNIFICANT CHANGE IN DAM OR KBDO REPORTABLE VALUES OVER 34 DAYS. THE RSDL FINISHED PRODUCT SAMPLES ALIQUOTED INTO AMBER GLASS VIALS AND STORED UNDER NORMAL ATMOSPHERE DID SHOW A SMALL BUT STATISTICALLY SIGNIFICANT CHANGE IN DAM AND KBDO REPORTABLE VALUES OVER 34 DAYS. WHILE THIS STUDY CONFIRMED THAT SAMPLE ALIQUOT STORAGE CONDITIONS ARE IMPORTANT TO SAMPLE INTEGRITY, IT DID NOT CONFIRM THAT A LAB ERROR OCCURRED WITH RESPECT TO SAMPLE HANDLING AND STORAGE. THEREFORE, THIS INVESTIGATION PROCEEDS TO PHASE II WHICH IS ONGOING AT THIS TIME. THE OUTCOME OF THE REPORTED EVENT WAS NOT APPLICABLE; THERE WAS NO PATIENT OR CONSUMER EXPOSURE. ACTION TAKEN WITH RSDL WITH RESPECT TO THE REPORTED EVENT WAS NOT APPLICABLE. NO FURTHER INFORMATION WAS PROVIDED. COMPANY COMMENT: THIS CASE WAS RECEIVED ON 10MAR2025, FROM A COMPANY REPRESENTATIVE REGARDING THE RSDL DEVICE (DEKON 139, CONTAINING METHOXYPOLYETHYLENE GLYCOL 550 AND 2,3-BUTANEDIONE MONOXIME; LOT NUMBER: 23002949; EXPIRY DATE: 09OCT2024). IT WAS REPORTED THAT "RSDL BATCH 23002949 (57 MONTHS / 25-DEGREE CELSIUS/ 60 PERCENT RH) FAILED TO MEET STABILITY SPECIFICATIONS FOR THE DETERMINATION OF POTASSIUM 2,3-BUTANEDIONE MONOXIMATE (KBDO) CONTENT AND DIACETYL MONOXIME (DAM) CONTENT IN REACTIVE SKIN DECONTAMINATION LOTION (RSDL) AT THE 57-MONTH TIME POINT OR END OF SHELF LIFE. IT SHOULD BE NOTED THAT AT THE 48-MONTH STABILITY TIME POINT (JAN-2024) AN OOS INVESTIGATION WAS CONDUCTED FOR DAM AND KBDO OF THE SAME BATCH. HOWEVER, RETEST RESULTS DID NOT CONFIRM THE ORIGINAL OOS RESULT, WITH ¿METHOD¿ CONSIDERED THE PROBABLE ROOT CAUSE. THE EVENT OF OUT OF SPECIFICATION TEST RESULTS IS CONSIDERED AS SERIOUS (OTHER- MALFUNCTION). THE CAUSALITY OF OUT OF SPECIFICATION TEST RESULTS HAS BEEN ASSESSED AS NOT RELATED TO RSDL, OR TO THE USE OF RSDL. RSDL IS USED TO NEUTRALIZE OR REMOVE CHEMICAL AGENTS OR T2 TOXINS FROM THE SKIN. WHILE THIS ISSUE MAY AFFECT THE PRODUCT'S EFFICACY, IT WAS NOT ASSOCIATED WITH ANY ADVERSE EVENTS (AE). THERE IS A POTENTIAL RISK THAT THE PRODUCT MAY BE LESS EFFECTIVE IF EXPOSED TO A CHEMICAL AGENT, WHICH COULD POTENTIALLY LEAD TO SERIOUS INJURY OR DEATH IF IT WERE TO RECUR. HOWEVER, NO ADVERSE EVENTS WERE REPORTED, AND THE PRODUCT HAS SINCE EXPIRED. CASE COMMENTS: NA.