D-0411-2024 Class II Terminated
FDA drug recall D-0411-2024 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: 2,458, 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
- 2,458, syringes
Product Description
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 1223047334 Exp 12/23/23; 1223048170 Exp 02/01/24
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0411-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026