Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Reason for recall: Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. Distribution: Worldwide distribution - US Nationwide and the countries of Panama, Canada. Quantity: 568,849 units Lot/code info: a) 65145, UDI/DI 60653160023758 (case) 00653160023756 (each), Lot Numbers: 2023071990, 2023100390; b) 65940, UDI/DI 70653160018805 (case) 00653160018806 (each), Lot Numbers: 2023112290; c) 65945, UDI/DI 60653160024823 (case) 00653160024821 (each), Lot Numbers: 2023041290, 2023042890, 2023050190, 2023051890, 2023051990, 2023052290, 2023052490, 2023052590, 2023062090, 2023071490, 2023071790, 2023090290, 2023110190; d) 66150, UDI/DI 60653160023765 (case) 00653160023763 (each), Lot Numbers: 2023041390, 2023071490, 2023091890, 2023101190; e) 66155, UDI/DI 70653160022970 (case) 00653160022971 (each), Lot Numbers: 2023030390, 2023032990, 2023033090, 2023041890, 2023071090; f) 66215, UDI/DI 60653160004863 (case) 00653160004861 (each), Lot Numbers: 2023052690, 2023102790; g) 66260, UDI/DI 60653160008366 (case) 00653160008364 (each), Lot Numbers: 2023022290; h) 66350, UDI/DI 50653160018306 (case) 00653160018301 (each), Lot Numbers: 2023062790, 2023091190; i) 66365, UDI/DI 10653160025672 (case) 00653160025675 (each), Lot Numbers: 2023041990, 2023072890; j) 66450, UDI/DI 60653160022348 (case) 00653160022346 (each), Lot Numbers: 2023022890, 2023030190; k) 66465, UDI/DI 10653160023067 (case) 00653160023060 (each), Lot Numbers: 2023063090; l) 66665, UDI/DI 60653160082717 (case) 00653160082715 (each), Lot Numbers: 2023061490, 2023071990, 2023100690; m) 66710, UDI/DI 70653160046341 (case) 00653160046342 (each), Lot Numbers: 2023111090; n) 66820, UDI/DI 60653160028289 (case) 00653160028287 (ea
60653160023758, 00653160023756, 70653160018805, 00653160018806, 60653160024823, 00653160024821, 60653160023765, 00653160023763, 70653160022970, 00653160022971, 60653160004863, 00653160004861, 60653160008366, 00653160008364, 50653160018306, 00653160018301, 10653160025672, 00653160025675, 60653160022348, 00653160022346, 10653160023067, 00653160023060, 60653160082717, 00653160082715, 70653160046341, 00653160046342, 60653160028289, 00653160028287, 60653160048058, 00653160048056, 50653160049256, 00653160049251, 60653160049246, 00653160049244, 50653160006563, 00653160006568, 60653160048393, 00653160048391, 50653160052195, 00653160052190
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.