United StatesBicarby Dialysate (Model RFP-400-G; UDI‑DI 00840861102839; lot codes 25SG06026 and 25SG06027), 4,752 units sold in Texas, is being recalled. The GTIN on the product label is incorrect; if that GTIN is used as the sole means of identification, it could lead to unrecognized use of a potassium solution with a concentration differing from the prescription, although the case labeling, lot number, and printed labeling correctly identify the product.
What's being recalled
Bicarby Dialysate; Model number: RFP-400-G;
Recalling firm: Fresenius Medical Care Holdings, Inc., Waltham, MA, United States.
How to identify it
Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;
The hazard
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Domestic: TX.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)