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

SCA Pharmaceuticals, LLC: HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd.,

Hazard

Lack of Assurance of Sterility

Details from the source

Reason for recall: Lack of Assurance of Sterility Distribution: Nationwide in the USA Quantity: 5392 syringes Lot/code info: Lot #: 1223048357 Exp 11/15/23; 1223048461 EXP 11/20/23; 1223048486 EXP 11/21/23; 1223048694 EXP 12/01/23; 1223048865 EXP 12/06/23; 1223048967 EXP 12/11/23; 1223049098 EXP 12/15/23; 1223049133 EXP 12/19/23; 1223049175 EXP 12/20/23; 1223049268 EXP 12/25/23; 1223049457 EXP 01/01/24; 1223049561 EXP 01/04/24; 1223049604 EXP 01/05/24; 1223049648 EXP 01/09/24; 1223049870 EXP 01/17/24; 1223049942 EXP 01/19/24; 1223049973 EXP 01/23/24; 1223050060 EXP 01/25/24;

Source

Official record: FDA (Drug enforcement)

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

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