January 2022 FDA Recall Drug by Exela Pharma Sciences Llc
D-0369-2022 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Exela Pharma Sciences Llc on January 11, 2022 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0369-2022
Lack of Assurance of Sterility
01-11-2022
01-19-2022
18,960 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Exela Pharma Sciences LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
12-02-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
Batch or Lot Expiration Information
Lot# : C0001088/P0001317, Exp. Date 08/2023
