Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Reason for recall: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Distribution: Nationwide in the USA. Quantity: 12,888 bags Lot/code info: Lot # 37-890033, 37-890035, Exp 04/28/2023; 37-890518, 37-890527, 37-890536, 37-890538, Exp 04/29/2023; 37-890844, 37-890845, Exp 04/30/2023; 37-891159, 37-891161, 37-891187, 37-891190, 37-891212, 37-891213, 37-891222, 37-891223, Exp 05/01/2023; 37-891432, 37-891433, 37-891434, 37-891435, 37-891440, 37-891442, 37-891445, 37-891446, 37-891447, Exp 05/02/2023; 37-891746, 37-891754, 37-891755, Exp 05/05/2023; 37-892005, 37-892007, Exp 05/06/2023; 37-892502, 37-892503, 37-892505, 37-892517, 37-892518, 37-892519, 37-892538, Exp 05/07/2023; 37-892871, 37-892873, 37-892874, 37-892879, 37-892880, 37-892886, 37-892887, 37-892888, 37-892899, Exp 05/08/2023; 37-893129, 37-893131, 37-893158, 37-893160, 37-893162, 37-893163, 37-893164, Exp 05/09/2023; 37-893681, 37-893689, 37-893698, 37-893760, 37-893761, 37-893762, Exp 05/13/2023; 37-894275, 37-894276, 37-894277, 37-894301, Exp 05/14/2023; 37-894651, 37-894654, 37-894658, 37-894660, 37-894662, 37-894663, Exp 05/15/2023; 37-894948, 37-894967, 37-894970, Exp 05/16/2023; 37-895276, 37-895278, 37-895281, 37-895284, 37-895285, 37-895286, 37-895289, 37-895297, Exp 05/19/2023; 37-895650, 37-895652, Exp 05/20/2023; 37-896051, 37-896052, 37-896054, 37-896055, 37-896057, 37-896058, 37-896455, Exp 05/21/2023; 37-896418, 37-896419, 37-896420, 37-896438, 37-896453, 37-896454, 37-896855, Exp 05/22/2023; 37-896814, 37-896816, 37-896818, 37-896823, 37-896824, 37-896841, 37-896843, 37-896942, Exp 05/23/2023; 37-897417, 37-897429, Exp 05/27/2023; 37-89785
3700000900051
Official record: FDA (Drug enforcement) ↗
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