EXTRANEAL CLEAR-FLEX

Main information

  • Trade name:
  • EXTRANEAL CLEAR-FLEX Solution for peritoneal dialysis
  • Pharmaceutical form:
  • Solution for peritoneal dialysis
  • Administration route:
  • Intraperitoneal use
  • Units in package:
  • 3X2,5L TWIN II Bag
  • Prescription type:
  • on prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EXTRANEAL CLEAR-FLEX Solution for peritoneal dialysis
    Czech Republic
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • ISOTONIC SOLUTIONS
  • Product summary:
  • EXTRANEAL CLEAR-FLEX

Other information

Status

  • Source:
  • SUKL - Státní ústav pro kontrolu léčiv
  • Authorization status:
  • B - medicinal product after change, may be placed on the market
  • Authorization number:
  • 87/ 340/15-C
  • Last update:
  • 21-06-2017

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

There are no news related to this product.