Recall Enforment Report D-0022-2023

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Exela Pharma Sciences LLC, originally initiated on 10-04-2022 for the product 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1 The product was recalled due to defective container: complaints received of vial breakage and glass flying when pressurized while preparing the product for administration. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0022-2023	10-04-2022	11-02-2022	Class I	2,123,040 vials	8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1	Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration	Ongoing
D-0023-2023	10-04-2022	11-02-2022	Class I	148,920	8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.	Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration	Ongoing

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
51754-5001	Sodium Bicarbonate	Sodium Bicarbonate	Injection, Solution	Intravenous	Exela Pharma Sciences, Llc	Human Prescription Drug
51754-5002	Sodium Bicarbonate	Sodium Bicarbonate	Injection, Solution	Intravenous	Exela Pharma Sciences, Llc	Human Prescription Drug
51754-5011	Sodium Bicarbonate	Sodium Bicarbonate	Injection, Solution	Intravenous	Exela Pharma Sciences, Llc	Human Prescription Drug
51754-5012	Sodium Bicarbonate	Sodium Bicarbonate	Injection, Solution	Intravenous	Exela Pharma Sciences, Llc	Human Prescription Drug
72572-740	Sodium Bicarbonate	Sodium Bicarbonate	Injection, Solution	Intravenous	Civica	Human Prescription Drug

Field Name	Field Value
Event ID	90956 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0022-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1
Reason For Recall	Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	2,123,040 vials Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	11-02-2022
Recall Initiation Date	10-04-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Exela Pharma Sciences LLC
Code Info	Lot # : P0001370, P0001371, P0001372, Exp. 10/2023; P0001433, P0001434 Exp. 11/2023; P0001443, P0001468, P0001469, P0001470, P0001495, P0001505, P0001506, P0001509, P0001510, P0001511, P0001512 Exp. 12/2023; P0001560, P0001561, P0001562, P0001564, P0001566, P0001567, P0001568 Exp. 01/2024; P0001571, P0001572, P0001573, P0001574, P0001578, P0001579, P0001580, P0001583, P0001586, P0001587, P0001588, P0001593, P0001594, P0001610, P0001618, P0001619, P0001654 Exp. 02/2024; P0001644, P0001645, P0001646, P0001662, P0001664 Exp. 03/2024; P0001730 Exp. 05/2024. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	51754-5001-5; 51754-5001-4; 51754-5011-4; 51754-5002-5; 51754-5012-4; 51754-5001-1
Status	Ongoing

Field Name	Field Value
Event ID	90956 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0023-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
Reason For Recall	Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	148,920 Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	11-02-2022
Recall Initiation Date	10-04-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Exela Pharma Sciences LLC
Code Info	Lot #: P0001497 Exp. 12/2023; P0001600 Exp. 02/2024; P0001663 Exp. 03/2024 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	72572-740-20; 72572-740-25
Status	Ongoing