D-0409-2024 Class II Terminated
FDA drug recall D-0409-2024 was initiated by SCA Pharmaceuticals, LLC on Nov 9, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Aug 27, 2024). Affected quantity: 5392 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 3, 2024
- Initiation Date
- Nov 9, 2023
- Termination Date
- Aug 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5392 syringes
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
Distribution Pattern
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;
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0409-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026