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: 499,304 Syringes Lot/code info: Lot: 36-239063, 36-239064, 36-239065, 36-239066, 36-239067, 36-23906, 736-239068, 36-239069, 36-239204, Exp. 7/10/2023; 36-239196, 36-239197, 36-239198, 36-239199, 36-239200, 36-239201, 36-239202, 36-239203, 36-239205, 36-239206, Exp. 7/11/2023; 36-239483, 36-239487, 36-239488, 36-239489, 36-239490, 36-239639, 36-239640, 36-239641, Exp. 7/12/2023; 36-239788, 36-239789,36-239790, 36-239793, 36-239797, 36-239798, Exp. 7/13/2023; 36-240139, 36-240140, 36-240141, 36-240142, 36-240143, Exp. 7/16/2023; 36-240319, 36-240320, 36-240321 ,36-240322, 36-240812, Exp. 7/17/2023; 36-241074, 36-241075, 36-241076, 36-241077, Exp. 7/18/2023; 36-241136, Exp. 7/19/2023; 36-241357, 36-241358, 36-241359, 36-241372, 36-241373, Exp. 7/20/2023; 36-241715, 36-241718, 36-241719, 36-241720, 36-241721, 36-241723, 36-241850, Exp. 7/21/2023; 36-241918, 36-241919, 36-241920, 36-242184, Exp. 7/23/2023; 36-241993, 36-241994, 36-241995, 36-241997, Exp. 7/24/2023; 36-242402, 36-242403, 36-242404, 36-242405, 36-242406, 36-242913, Exp. 7/25/2023; 36-242630, 36-242631, 36-242632, 36-242633, 36-242634, Exp. 7/26/2023; 36-242799, 36-242800, 36-242801, 36-242802, 36-242803, 36-242806, Exp. 7/27/2023; 36-243537, 36-243538, 36-243539, Exp. 7/30/2023; 36-243820, 36-243822, 36-244311, 36-243819, Exp. 7/31/2023; 36-244877, 36-244878, 36-244879, 36-245572, 36-245574, Exp. 8/1/2023; 36-245805, 36-246140, 36-246141, 36-246142, 36-246143, Exp. 8/2/2023; 36-246292, 36-246293, 36-246294, 36-246295, 36-246296, 36-246297, Exp. 8
Official record: FDA (Drug enforcement) ↗
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