Recall Enforment Report D-0015-2023

Drug Recall Enforcement Report Class II voluntary initiated by Fresenius Medical Care Holdings, Inc., originally initiated on 10-11-2022 for the product 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10 The product was recalled due to lack of assurance of sterility: leakage of 0.9% sodium chloride for injection, 1l, 12pk saline solution.. The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 90997 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0015-2023 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class 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 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 in the USA 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 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
Reason For Recall Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 16,006 cases of twelve bags each 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 10-26-2022
Recall Initiation Date 10-11-2022 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 Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit 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 Fresenius Medical Care Holdings, Inc.
Code Info Lot # 22EU05043, EXP 5/21/2023; 22HU05018, EXP 6/9/2023; 22HU05019, EXP 6/10/2023; 22HU05025, 22HU05026, EXP 6/12/2023; 22HU05049, EXP 6/22/2023; 22HU05053, EXP 6/24/2023; 22HU05054, 22HU05055, EXP 6/25/2023; 22HU06027, EXP 6/11/2023; 22HU06049, EXP 6/23/2023; 22HU06055, EXP 6/24/2023; 22HU06056, EXP 6/25/2023; 22JU05008, EXP 7/4/2023; 22KU06036, EXP 8/19/2023; 22JU06023, EXP 7/8/2023 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 49230-300-10
Status Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
49230-300Sodium Chloride Sodium ChlorideInjectionIntravenousFresenius Medical Care North AmericaHuman Prescription Drug