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Dex4 Grape FDA Alerts

The FDA Alerts below may be specifically about Dex4 Grape or relate to a group or class of drugs which include Dex4 Grape.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Dex4 Grape

25 Percent Dextrose Injection, USP (Infant) by Hospira: Recall - Particulate Matter

Apr 24, 2017 | Audience: Pharmacy

ISSUE: Hospira is voluntarily recalling one lot of 25% Dextrose Injection, USP, (Infant) pre-filled syringe to the hospital/user level due to the presence of particulate matter, identified as human hair, found within an internal sample syringe. The affected lot is NDC: 0409-1775-10, Lot 58382EV, Expiry Date 1OCT 2017

In the event that the particulate is administered to a patient, it could result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or systemic allergic response to the particulate. Administration of the particulate could also result in localized phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, and pulmonary infarction.

BACKGROUND: 25% Dextrose Injection, USP (Infant) is indicated for use via slow IV injection to treat symptomatic episodes of hypoglycemia (fasting blood glucose < 40 mg/100 ml) in neonates or older infants to restore depressed blood glucose values and control symptoms.

25% Dextrose Injection, USP (Infant) 2.5 grams (250 mg/mL), 10 mL Single-dose prefilled syringe, NDC: 0409-1775-10, Lot 58382EV, Expiry Date 1OCT 2017 is packaged in a carton containing 1 pre- filled syringe per carton, 5 x 10 syringes per case. The lot was distributed from February 2016 through October 2016 nationwide in the United States and Puerto Rico.

RECOMMENDATION: Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Inform health care professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital/user level. For additional assistance, call Stericycle at 1-888-570-1678 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[04/21/2017 - Press Release - Hospira]

5 Percent Dextrose Injection USP in PAB Container by B. Braun Medical: Recall - Leakage and/or Particulate Matter

Mar 29, 2016 | Audience: Pharmacy, Nursing

ISSUE: B. Braun Medical Inc. is recalling one lot of 5% Dextrose Injection USP 100/150mL container (Lot #J5J706, catalog #S5104-5264, NDC 0264-1510-32) to the consumer level. B. Braun recently identified an adverse quality trend in customer complaints reporting that some containers in lot J5J706 exhibited leakage and, in a few instances, visible particulate matter identified to be microbial growth.

A compromise of container integrity has the potential for leakage of the solution, usually identified prior to the use of the product. Leaking containers allow contamination of the solution, which can and has led to microbial contamination. Intravenous administration of a non-sterile product can result in serious infections that may be life-threatening.

BACKGROUND: This product is intended for intravenous administration and may be used as a diluent and delivery system for intermittent administration of compatible drug additives. The product is packaged in B. Braun's PAB (Partial Additive Bag) container with 64 units per case. The affected lot J5J706, which expires 10/31/2016, was distributed nationwide to licensed distributors, hospitals, and pharmacies.

RECOMMENDATION: B. Braun is notifying its distributors and customers by certified mail and is arranging for the return of all recalled product. Distributors and customers that have inventory of lot J5J706, 5% Dextrose Injection USP 100/150mL container, should discontinue use immediately and contact B. Braun Medical Inc.'s Customer Support Department at 1-800-227-2862 Monday through Friday, 8 a.m. to 6 p.m. (EST) for instructions for returning the affected product and to arrange for replacement product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[03/29/2016 - Press Release - B. Braun Medical]
 

Baxter IV Solutions: Recall - Potential Presence of Particulate Matter

Jan 5, 2016 | Audience: Pharmacy

Includes:

  • 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container
  • 70% Dextrose Injection (2000 mL) USP

ISSUE: Baxter International Inc. announced a voluntarily recall of two lots of intravenous (IV) solutions to the hospital/end user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint.

The lots being recalled were distributed to customers and distributors in the United States between June 6, 2015 and December 16, 2015. See the Press Release for affected lot numbers.

Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.

BACKGROUND: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container is intended for IV use as a source of water and electrolytes and may also be used as a priming solution in hemodialysis procedures. 70% Dextrose Injection (2000 mL) USP is indicated as a source of calories and water for hydration.

RECOMMENDATION: Baxter is directing customers not to use the product from the recalled lots. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7 a.m. and 6 p.m., Central Time. Unaffected lots of product are available for replacement. This recall is not expected to affect current supply and product remains available for current customers.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[12/18/2015 - Press Release - Baxter]