HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL f...
FDA Recall #D-0409-2024 — Class II — November 9, 2023
Product Description
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., Windsor, CT 06095, NDC 70004-0303-16, Bar Code 70004030316
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
SCA Pharmaceuticals, LLC — Windsor, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5392 syringes
Distribution
Nationwide in the USA
Code Information
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;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated