FDA issues warning letter to Fresenius Kabi over famotidine injection contamination

FDA inspectors spent three weeks at Fresenius Kabi's plant in Melrose Park, Illinois, and issued a warning letter after finding manufacturing deviations linked to patient adverse events.

The issue involved the company's famotidine injection, an H2 blocker for heartburn and ulcers, where batches exceeded bioburden limits and showed endotoxin contamination, leading to pyrogenic reactions such as fever.

The FDA said the firm failed to adequately investigate the deviation and released the product despite test results, prompting a recall of three affected famotidine batches.