Recall of Kidney Disease Drug Kremezin: TFDA Orders Withdrawal of 1.38 Million Tablets from 2 Batches
NQ Score
83/100
N1 Content Completeness
9
AI Summary (NQ-processed)
Taiwan's TFDA has ordered the recall of two batches of Kremezin Tablets 500mg, a uremic adsorbent for chronic kidney disease patients, due to deviations in solvent residue testing methods during manufacturing. Approximately 1.38 million tablets have been recalled.
AI Analysis
Frequently Asked Questions
- Q: Why is Kremezin being recalled?
- A: Due to a deviation in residual solvent testing during manufacturing, a preventive recall was initiated.
- Q: Is it safe if I already took the medication?
- A: No adverse events have been reported, but patients should return the product as instructed.
- Q: Will there be a drug shortage?
- A: Unaffected batches are available in stock, and supply will continue without disruption.