Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Fluid leakage and low fill volume may cause a lack in sterility
Company Name:
B. Braun Medical Inc.
Brand Name:
B. Braun Medical Inc.
Product Description:
0.9% Sodium Chloride for Injection USP 250ML in Excel
Company Announcement
B. Braun Medical Inc. (B. Braun) is voluntarily recalling five (5) lots of 0.9% Sodium Chloride for Injection USP 250ML in Excel within the United States to the hospital/user level. The voluntary recall has been initiated due to fluid leakage or low fill volume of the respective containers.
The biggest risk with a slow leak in any intravenous solution preparation is a break in sterility which poses a risk for the patient being exposed to a bacterial or fungal infection. There is a remote probability this could lead to bloodstream infection. B. Braun has not received any reports of adverse events related to this recall.
0.9% Sodium Chloride for Injection USP in Excel is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion. 0.9% Sodium Chloride Injection USP in Excel is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells.
Product Catalog Number:
Lot Number:
NDC:
Product Description:
Distribution Date Range:
Expiration Date:
Region Distributed:
L8002
J1E086
0264-7800-20
0.9% NACL INJ USP 250ML
15JUN2021 – 22JUL2021
31-May-23
United States
J1E204
0264-7800-20
0.9% NACL INJ USP 250ML
17JUN2021 – 21JUL2021
31-May-23
United States
J1E213
0264-7800-20
0.9% NACL INJ USP 250ML
02JUN2021 – 28JUN2021
31-May-23
United States
J1H137
0264-7800-20
0.9% NACL INJ USP 250ML
14JUL2021 – 20OCT2021
30-Jun-23
United States
J1H138
0264-7800-20
0.9% NACL INJ USP 250ML
14JUL2021 – 29OCT2021
30-Jun-23
United States
Product was distributed Nationwide within the United States to domestic distributors.
B. Braun is notifying its distributors and customers by an official recall notice sent via certified registered mail and is arranging for return of all recalled products. Facilities and distributors that have product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department at 800-227-2862 Monday through Friday, 8 a.m. – 6 p.m. EST to arrange for product return.
Facilities with questions regarding this recall can contact B. Braun by phone at 800-227-2862 Monday through Friday, 8 a.m. – 6 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Center for Food Safety and Applied Nutrition (CFSAN)
Seafood HACCP/CGMP for Foods/Adulterated
Tuesday, March 8, 2022
On March 7, a consent decree of permanent injunction was signed by a judge requiring Salud Natural Entrepreneur, Inc. of Illinois not to engage in any distribution operations until it completes corrective actions to ensure the company is in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). The company distributed adulterated and misbranded dietary supplements and unapproved new drugs that it claimed would cure, mitigate, treat or prevent diseases such as cancer, diabetes, high blood pressure and heart disease. The FDA will continue to hold manufacturers responsible for the sale of mislabeled dietary supplements and for unlawful claims to cure, treat, and mitigate diseases, as this can be potentially harmful to consumers.
The Food and Drug Administration is advising consumers not to purchase or use Wonderful Honey, a product promoted for sexual enhancement on various websites and possibly in some retail stores. This product was discovered during an examination of imported goods.
FDA laboratory analysis confirmed that Wonderful Honey contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction. FDA approval of Viagra is restricted to use under the supervision of a licensed health care professional. This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Health care professionals and consumers should report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Note: This notification is to inform the public of products marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. These products are typically promoted for sexual enhancement, weight loss, or body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review
Decision Regarding Slick-Haired Cattle is Agency’s First Enforcement Discretion Decision for an Intentional Genomic Alteration in an Animal for Food Use
Today, the U.S. Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination). The IGA results in the equivalent genotype (genetic make-up) and short-hair coat trait seen in some conventionally bred cattle, known as a “slick” coat. This is the FDA’s first low-risk determination for enforcement discretion for an IGA in an animal for food use.
