Category: Recalls and Warnings

Recall: Baxter Revaclear Dialyzers

The FDA has announced a Class II recall of 59 lots of Baxter Revaclear 300 Dialyzer, Product Code 114745L, and 3 lots of Baxter Revaclear 400 Dialyzer, Product Code 114746L, totaling 1.3 million units. These HD dialyzers may leak blood during dialysis because there is potential for fibers in the dialyzer to rupture. For details see for the Revaclear 300, and for the Revaclear 400.

Recall: Antibacterials Amikacin, Prochlorperazine

The FDA has announced the recall of one lot each of two antibacterials manufactured by Emcure Pharmaceuticals and distributed by Heritage Pharmaceuticals, because of non-sterility:

  • Amikacin Sulfate Injection USP 250mg/mL Lot# VEAC025 Expiry October 2019
  • Prochlorperazine Edisylate Injection USP 5mg/mL Lot# VPCA172 Expiry April 2020

For details see