May 2023 FDA Recall Sodium Chloride by Fresenius Medical Care Holdings, Inc.
D-0777-2023 - Lack of assurance of sterility

This Class II drug recall was voluntarily initiated by Fresenius Medical Care Holdings, Inc. on May 23, 2023 for the product Sodium Chloride. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Product was distributed to 32 clinics in SC, NC and VA. and the recall is currently terminated.

Recall Number: D-0777-2023

Reason for Recall
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Initiated
05-23-2023
Reported
06-07-2023
Quantity
53,424 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92403
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Medical Care Holdings, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to 32 clinics in SC, NC and VA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-23-2024
Product Description About Product Description
Full technical description of the product.
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10

Batch or Lot Expiration Information

Lot# 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024

Affected Packages Involved in this Recall

49230-300-10 Sodium Chloride