Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Wa
Summary
The FDA issued a Class II for Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, by Fresenius Medical Care Holdings, Inc.. Reason: Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging..
Details
Source
Drug Recall
External ID
D-0777-2023
Action Date
2023-06-07
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024
Quantity Affected: 53,424 bags
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.
Distribution
Product was distributed to 32 clinics in SC, NC and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-23
Company
Waltham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 243 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Fresenius Medical Care Holdings, Inc. has 69 FDA actions in our database, including 69 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Medical Care Holdings, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Medical Care Holdings, Inc. have FDA actions?
Fresenius Medical Care Holdings, Inc. has 69 FDA actions in our database, including 69 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0777-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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