Drug Enforcement D-0620-2025

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

Status

Ongoing

Classification

Class II

Report Date

September 17, 2025

Termination Date

—

Product Information

Product description
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)
Product quantity
N/A
Reason for recall
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Recall initiation reason
—
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Exela Pharma Sciences LLC
Address
1245 Blowing Rock Blvd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0620-2025
Event ID
97348
Recall initiation date
July 30, 2025
Center classification date
September 5, 2025
Code info
Lot # 10004077, Exp. 02/28/2026
More code info
—