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FDA (Drug enforcement)Recalled 2023-07-17closedclass ii

Central Admixture Pharmacy Services Inc: HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suit

Hazard

Lack of assurance of sterility: Lack of validation data for sanitization cycles

Details from the source

Reason for recall: Lack of assurance of sterility: Lack of validation data for sanitization cycles Distribution: Nationwide in the USA Quantity: 3824 bags Lot/code info: Lot: 17-270599, 17-270600, Exp. 7/17/2023; 17-270785, Exp. 7/19/2023; 17-270969, Exp. 7/23/2023; 17-271116, 17-271135, Exp. 7/25/2023; 17-271242, Exp. 7/26/2023; 17-271502, Exp. 7/31/2023; 17-271561, 17-271589, Exp. 8/1/2023; 17-271672, Exp. 8/2/2023; 17-271837, Exp. 8/6/2023; 17-272291, Exp. 8/14/2023; 17-272363, 17-272364, Exp. 8/15/2023; 17-272453, Exp. 8/16/2023; 17-272607, Exp. 8/20/2023; 17-272706, Exp. 8/21/2023; 17-273148, Exp. 8/29/2023; 17-273421, Exp. 9/3/2023; 17-273698, 17-273700, Exp. 9/6/2023; 17-273966, Exp. 9/11/2023.

Source

Official record: FDA (Drug enforcement)

Republished from the official source above; details can change — the source record controls.

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