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令和 4年 9月 8日作成
一般的名称及び販売名
一般的名称: 酸素 販売名 : 日本薬局方酸素
対象ロット、数量及び出荷時期
容器記号番号: 1H02351, 1H15668, 1H38347, 1H49960, 1H52229, 1H56541, 1H63745, 1H68896, 1H69065, 1H69137, 1H69303, 1H74327, 1H83776, 1H89523, 1H94018, 1PEI0503, 1PEI14106, 1PEI14333, 1PEI15016, 1PEI17149, 1PEI25401, 1PEI25402, 1PEI25403, 1PEI25404, 1PEI25405, 1PEI25406, 1PEI25407, 1PEI25408, 1PEI25409, 1PEI25410, 1PEI25411, 1PEI25412, 1PEI25413, 1PEI25415, 1PEI25417, 1PEI25418, 1PEI25419, 1PEI25420, 1PEI25421, 1PEI25422, 1PEI25423, 1PEI25424, 1PEI25426, 1PEI25427, 1PEI25428, 1PEI25429, 1PEI25430, 1PEI25431, 1PEI25432, 1PEI25433, 1PEI25434, 1PEI25435, 1PEI25436, 1PEI25437, 1PEI25438, 1PEI25439, 1PEI25440, 1PEI25441, 1PEI25442, 1PEI25443, 1PEI25444, 1PEI25445, 1PEI25446, 1PEI25447, 1PEI25448, 1PEI25449, 1PEI25450, 1PEI2609, 1PEI31003, 1PEI32014, 1PEI37346, 1PEI40428, 1PEI40430, 1PEI45109, 1PEI46155, 1PEI50350, 1PEI51032, 1PEI52654, 1PEI56881, 1PEI58920, 1PEI58921, 1PEI58922, 1PEI62211, 1PEI62901, 1PEI65289, 1PEI73073, 1PEI9029, 1X17003, 1X17006, 1X17147, 1X31908, 1X53554, 1X55112, 1X61019, 1X73081, 1X91014, 1X95267, 2H00981, 2H05482, 2H11189, 2H14826, 2H22929, 2H23142, 2H23144, 2H25471, 2H27993, 2H27994, 2H30476, 2H30656, 2H55707, 2H65146, 2H84731, 2H84738, 2H87644, 2H87645, 2H92467, 2H92469, 2H92474, 2H92475, 2H92482, 2H92483, 2H92484, 2H97324, 2H97326, 2PEI43619, PEI64981, 2PEI65799, 2PEI65800, 2PEI6675, 2PEI7015, 2PEI71295, 2PEI73562, 2PEI73563, 2PEI74701, 2PEI74702, 2PEI75174, 2PEI75175, 2PEI79428, 2PEI79429, 2PEI79430, 2PEI79431, 2PEI79432, 2PEI82561, 2PEI93824, 2X39126, 2X41723, 2X49138, 2X50403, 2X58989, 2X59256, 2X59270, 2X59271, 2X59611, 2X62228, 2X68593, 2X70542, 2X73647, 2X73648, 2X79717, 2X98854, 3H13838, 3H18355, 3H28856, 3H32005, 3H32280, 3H40402, 3H40425, 3H63321, 3H65573, 3H68390, 3H68393, 3H70915, 3H74600, 3H97538, 3H97898, 3X38744, 3X60580, 4H08867, 4H19672, 4H33689, 4H35964, 4H39576, 4H39579, 4H39858, 4H39861, 4H42245, 4H48219, 4H52987, 4H53417, 4H53432, 4H53437, 4H53438, 4H53439, 4H53442, 4H53444, 4H53447, 4H53448, 4H53450, 4H53453, 4H53455, 4H53459, 4H53460, 4H56293, 4H56429, 4H56432, 4H66624, 4H66652, 4H66666, 4H66687, 4H70203, 4H70260, 4H75077, 4H75078, 4H75079, 4H75080, 4H75081, 4H77454, 4H81803, 4H91733, 4H92941, 4H94504, 4X29765, 4X30217, 4X39293, 4X65168, 4X71008, 4X78398, 5H00792, 5H04906, 5H19034, 5H22558, 5H22559, 5H28001, 5H36442, 5H37648, 5H42768, 5H42815, 5H48319, 5H50872, 5H51386, 5H53502, 5H65130, 5H65131, 5H65132, 5H65133, 5H65134, 5H65135, 5H65136, 5H65138, 5H65139, 5H65189, 5H65214, 5H69574, 5H73599, 5H73600, 5H75502, 5H78356, 5H87028, 5H87029, 5H87030, 5H87031, 5H87033, 5H87034, 5H87035, 5H87036, 5H87037, 5H88727, 5H88728, 5H91496, 5H92251, 5H92252, 5X11940, 5X20632, 5X20633, 5X35677, 5X49762, 5X50520, 5X50522, 5X60767, 5X60999, 5X69486, 5X77394, 5X94827, 6H03536, 6H06185, 6H06186, 6H06915, 6H12169, 6H17078, 6H17079, 6H21934, 6H22286, 6H22448, 6H22450, 6H27786, 6H27789, 6H30527, 6H30528, 6H37417, 6H40030, 6H49474, 6H49475, 6H49601, 6H54551, 6H54552, 6H54553, 6H56582, 6H56583, 6H67161, 6H73759, 6H86332, 6H92423, 6X25150, 6X70132, 6X70401, 6X95347, 7H08803, 7H26986, 7H26987, 7H33053, 7H37277, 7H49252, 7H49329, 7H70748, 7H70749, 7H70750, 7H70751, 7H70752, 7H70753, 7H70754, 7H70755, 7H70756, 7H70757, 7H70758, 7H70759, 7H70760, 7H70761, 7H70762, 7H70763, 7H70764, 7H70765, 7H70766, 7H70767, BYO00335, CD50860, CD50884, CD50885, CD54097, CD61052, CD62537, CD62565, CD62567, CD63645, CD63654, CD63655, CD68704, CD69026, CD70063, CD70353, CD70355, CD72905, CD8163, CD8797, CDA60186, CEM2642, CFD14526, CFD17438, CFD18489, CFD18515, CFD46231, CFD46268, CFD46333, CFD86468, CFD89041, CFD99633, CVM23973, CVM26705, CVM41660, CVM64140, VM64989, CVM69335, CVM80187, CVM91854, FX11268, FX13131, FX20569, FX54476, KCC34034, KH10776, KH14592, KH18892, KH21075, KH21080, KH21088, KH21091, KH21092, KH21097, KH24572, KH26354, KH26357, KH31725, KH32667, KH34795, KH37912, KH38377, KH42659, KH42661, KH42662, KH42663, KH42664, KH42665, KH43892, KH45282, KH45335, KH46765, KH48627, KH48703, KH50700, KH50701, KH53477, KH54619, KH54620, KH54621, KH54623, KH54624, KH54625, KH55912, KH55914, KH55916, KH55920, KH55977, KH55979, KH57970, KH57972, KH57974, KH58696, KH58697, KH58699, KH58709, KH58710, KH58711, KH58712, KH58715, KH61911, KH61912, KH61913, KH62006, KH62459, KH63302, KH64863, KH64864, KH66229, KH66607, KH67646, KH69662, KH69664, KH71179, KH75921, KH77687, KH77688, KH9065, KHA10364, KHA12159, KHA12435, KHA14485, KHA18828, KHA24705, KHA29707, KHA30122, KHA32729, KHA32757, KHA35286, KHA35287, KHA3533, KHA35897, KHA37524, KHA40984, KHA41000, KHA45341, KHA47092, KHA48974, KHA5121, KHA53469, KHA55231, KHA55246, KHA6137, KHA6138, KHA62800, KHA64617, KHA64618, KHA64619, HA64620, KHA68312, KHA71565, KHA72092, KHA7577, KHA76006, KHA79209, KHA82021, KHA83531, KHA83532, KHA86053, KHA90245, KW26022, KW55258, KW59402, KW75604, KW82654, KW85204, KW86550, KW86592, W88432, LA05202, LA08446, LA10219, LA53307, PEI13673, PEI14517, PEI14518, PEI14754, PEI14821, PEI16863, PEI17437, PEI21697, PEI24725, PEI25717, PEI26159, PEI2749, PEI2751, PEI28652, PEI28653, PEI30726, PEI31742, PEI32987, PEI32988, PEI33001, PEI36614, PEI3801, PEI3806, PEI39310, PEI39315, PEI45886, PEI46288, PEI46289, PEI47502, PEI47503, PEI47504, PEI47610, PEI47862, PEI49124, PEI49125, PEI5301, PEI53798, PEI54017, PEI58896, PEI63834, PEI70487, PEI70503, PEI72428, PEI7462, PEI7463, PEI7464, PEI75268, PEI75323, PEI79914, PEI80327, PEI80334, PEI85151, PEI89002, PEI89004, PEI93843, PEI93844, PEI93845, PEI94168, PEI97901, PEI99053, PEI99409, PIEA15072, PIEA33268, X3512, X3980, X43647, X43648, X43651, X52999, X56449, X71238 数 量:587本 出荷時期:2018年2月23日〜2022年8月18日
製造販売業者等名称
製造販売業者の名称 : 岩谷瓦斯株式会社 製造販売業者の所在地: 大阪府大阪市北区西天満四丁目8番17号 許可の種類 : 第二種医薬品製造販売業 許可番号 : 27A2X00216
回収理由
日本薬局方酸素に使用する高圧ガス容器には、高圧ガス保安法に基づき容器検査業者が 実施する容器再検査の際に、容器外面を塗装する工程があります。 今般、他社が容器再検査を依頼した容器検査業者より、2016年8月19日から2022年8月8日 の期間に容器再検査した一部容器の内面に、外面塗装に使用した塗料を確認した旨の 連絡がありました。 調査の結果、該当容器を使用して製品を製造販売していることが確認されたため、 自主回収を実施します。
危惧される具体的な健康被害
今回の回収原因は、容器検査業者での外面塗装工程の不備によります。 外面塗装に使用した粉体塗料はポリエステル系の樹脂であり、容器内部に入ってしまった 塗料は焼き付けにより完全に固まっており、製品と混ざることはないため、安全性への 影響は極めて低く、本件に起因する重篤な健康被害の恐れはないと考えています。 なお、現在までに本件に関連のある健康被害の報告は受けておりません。
回収開始年月日
令和4年9月8日
効能・効果又は用途等
(1)酸素欠乏による諸症状の改善 (2)日本薬局方窒素と混合し、合成空気として使用する
その他
対象製品の納入先は特定できておりますので、自主回収の旨を文書で情報提供し、 速やかに対象製品を自主回収致します。
担当者及び連絡先
担当者 : 本山 満弘 連絡先 : 岩谷瓦斯株式会社 品質管理部 電話番号: 06-6530-1023 FAX番号 : 06-6530-1015