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FDA (Drug enforcement)Recalled 2023-11-09closedclass ii

SCA Pharmaceuticals, LLC: PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 060

Hazard

Lack of Assurance of Sterility

Details from the source

Reason for recall: Lack of Assurance of Sterility Distribution: Nationwide in the USA Quantity: 5,948 syringes, expanded 2,102 syringes Lot/code info: Lot #: 1223045282 Exp 11/24/23; 1223045370 Exp 11/26/23; 1223045624 Exp 12/07/23; 1223045723 Exp 12/10/23; 1223045732 Exp 12/10/23; 1223046128 Exp 12/24/23; 1223046133 Exp 12/24/23; 1223047112 Exp 02/02/24; 1223047232 Exp 2/07/24; 1223047398 Exp 02/15/24; 1223047456 Exp 02/16/24; 1223047569 Exp 02/18/24; 1223047694 Exp 02/24/24; 1223047780 Exp 03/07/24; 1223047859 Exp 03/08/24; 1223048119 Exp 03/20/24; 1223048183 Exp 03/22/24; 1223048837 Exp 04/18/24; 1223048838 Exp 04/18/24; 1223048982 Exp 04/24/24; 1223049144 Exp 05/02/24; 1223049145 Exp 05/02/24; 1223049147 Exp 05/02/24; 1223049821 Exp 05/30/24 Expanded Lot #: 1223048037, Exp 03/16/2024; 1223048047, Exp 03/17/2024; 1223049146, 1223049149, Exp 05/02/2024; 1223049373, Exp 05/10/2024; 1223048909, Exp 04/20/2024; 1223048696, Exp 04/12/2024; 1223050181, Exp 06/12/2024

Source

Official record: FDA (Drug enforcement)

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

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