Κυριακή 5 Νοεμβρίου 2017

U.S.A.'s interesting latest


 
U.S. Food and Drug Administration Header

Setton International Foods Issues Allergy Alert for Undeclared Milk in Select Dark Chocolate Almonds and Dark Chocolate Raisins Products Received from our Supplier GKI Foods LLC
Setton International Foods, Inc. of Commack, NY, is voluntarily recalling select dark chocolate almonds and dark chocolate raisins products. All these products contain undeclared Milk. People with an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume these products.

The recalled retail package items: All Best Before dates
Deluxe Dark Chocolate Almonds 20oz. UPC: 034325078741
Deluxe Dark Chocolate Almonds 14oz. UPC:034325747661
Deluxe Dark Chocolate Raisins 24oz. UPC:034325078758
Deluxe Dark Chocolate Raisins 16oz. UPC:034325147669

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

[Posted 11/03/2017]

AUDIENCE: Pharmacy, Surgery, Risk Manager, Consumer

ISSUE: Fresenius Kabi USA is voluntarily recalling Lot of Midazolam Injection, USP, 2 mg/2 mL packaged in a 2 mL prefilled single-use glass syringe to the hospital/user level. The product mislabeled as Midazolam Injection,
USP, 2 mg/2 mL contains syringes containing and labeled as Ondansetron Injection, USP, 4 mg/2 mL.

BACKGROUND: A missed dose of midazolam may lead to ineffective sedation and/or anxiety related to patient recall of a surgical or diagnostic procedure. If a selection error occurs, a patient who may have received a pre-operative dose of ondansetron may inadvertently receive an additional dose of ondansetron. Dose-dependent serious cardiac arrhythmias may be observed with higher dosages of ondansetron in those patients with certain pre-existing cardiac conditions. Patients may also be at risk for serotonin syndrome. Serotonin syndrome is associated with increased serotonergic activity in the central nervous system. Most reports of serotonin syndrome have been associated with concomitant use of certain drugs, some commonly used during surgery, such as fentanyl. Some of the reported cases of serotonin syndrome were fatal.

RECOMMENDATION: Fresenius Kabi is notifying its distributors and customers by letter and is arranging for return of the recalled product. If health care facilities have the affected lot, they are to immediately discontinue distributing, dispensing or using the lot and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped, or may have been shipped the product involved in this recall.

Consumers with questions regarding this recall can contact Fresenius Kabi Quality Assurance at 1-866-716-2459. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug 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:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • 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
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm583860.htm
Ridge Properties DBA Pain Relief Naturally Issues Voluntary Nationwide Recall of all lots of Naturally HL Bedsore Cream, Pretat by TAT Balm Carbomer Free Gel, & All Naturally HL Hemorrhoid products due to manufacturing concerns at the facility

Ridge Properties DBA Pain Relief Naturally is voluntarily recalling all lots within expiry of Naturally HL Bedsore Relief Cream, Extra Strength PreTAT by TAT Balm Carbomer Free Gel and Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine manufactured by Ridge Properties dba Pain Relief Naturally, Salem, Oregon to the consumer level. These products are being recalled after an FDA inspection found significant violations of current good manufacturing practice regulations.

Manufacturing practices that are not in adequate control represent the possibility of risk being introduced into the manufacturing process in decreased quality and consistency (i.e., the safety, identity, strength, quality and purity). Ridge Properties has received reports of subpotency in Extra Strength PreTAT by TAT Balm Carbomer Free Gel
Physio-Control announced today that the company is launching a voluntary field action for specific production lots of Infant/Child Reduced Energy Defibrillation Electrodes (defibrillation electrodes) produced by Cardinal Health.
The company is notifying customers of an issue with the artwork on the defibrillation electrodes, as manufactured by Cardinal Health, which shows incorrect electrode placement for an infant. There is no issue with the performance or function of the defibrillation electrodes; this is limited to incorrect artwork on the defibrillation electrodes within the packaging. If the user incorrectly places the defibrillation electrodes, it may result in ineffective energy delivery to the patient and serious injury or death.
The defibrillation electrodes are used only with LIFEPAK EXPRESS® AED, LIFEPAK CR® Plus AED, LIFEPAK® 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connector. Adult defibrillation electrodes are not impacted. Approximately 14,200 electrodes have been affected. There have been no customer complaints reported for this issue.

at

Δεν υπάρχουν σχόλια:

Δημοσίευση σχολίου