Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Distribution: Nationwide in the USA Quantity: 130,250 bags Lot/code info: Lot: 36-238820, 36-238821, 36-238822, 36-238824, 36-238825, Exp. 7/10/2023; 36-239686, 36-239687, 36-239688, 36-239689, 36-239690, 36-239691, 36-239692, 36-239693, 36-239696, 36-239697, 36-239699, 36-239700, Exp. 7/12/2023; 36-239915, 36-239916, 36-239917, 36-239918, 36-239919, 36-239922, 36-239923, Exp. 7/13/2023; 36-240165, 36-240168, 36-240170, 36-240171, 36-240173, 36-240174, Exp. 7/16/2023; 36-240260, 36-240261, 36-240262, Exp. 7/17/2023; 36-240823, 36-240824, 36-240826, 36-240827, 36-240828, 36-240829, 36-240830, 36-240831, 36-240832, 36-240833, 36-240834, Exp. 7/18/2023; 36-241141, 36-241142, 36-241143, 36-241144, 36-241145, 36-241146, 36-241439, Exp. 7/19/2023; 36-241511, 36-241515, 36-241517, 36-241518, 36-241523, 36-241526, 36-241528, Exp. 7/20/2023; 36-241671, 36-241672, 36-241673, 36-241675, 36-241677, 36-241679, 36-241682, 36-241684, 36-241689, Exp. 7/21/2023; 36-241824, 36-241826, 36-241827, 36-241828, 36-241829, 36-241830, 36-241833, 36-241835, 36-241837, 36-241839, 36-241841, 36-241843, 36-241844, 36-241845, 36-241846, Exp. 7/23/2023; 36-241998, 36-242000, 36-242002, 36-242005, 36-242009, 36-242026, 36-242037, 36-242040, 36-242209, 36-242208, Exp. 7/24/2023; 36-242421, 36-242427, 36-242431, 36-242442, 36-242447, 36-242456, 36-242464, 36-242465, Exp. 7/25/2023; 36-242708, 36-242712, 36-243054, Exp. 7/26/2023; 36-243154, 36-243158, 36-243160, 36-243175, 36-243204, 36-243647, 36-243648, Exp. 7/27/2023; 36-243548, 36-243549, Exp. 7/30/2023; 36-243840, 36-243841, E
Official record: FDA (Drug enforcement) ↗
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