D-0407-2024 Class II Terminated
FDA drug recall D-0407-2024 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: 1,023 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
- 1,023 syringes
Product Description
HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot#: 1223048801 Exp 12/04/23; 1223049225 Exp 12/21/23; 1223049264 Exp 12/25/23; 1223049291 Exp 12/26/23; 1223049726 exp 01/11/24
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0407-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026