labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharm...
FDA Recall #D-0411-2024 — Class II — November 9, 2023
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
Recalling Firm
SCA Pharmaceuticals, LLC — Windsor, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2,458, syringes
Distribution
Nationwide in the USA
Code Information
Lot #: 1223047334 Exp 12/23/23; 1223048170 Exp 02/01/24
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated