OTC Drugmaker Draws FDA Warning for Microbial Testing

The FDA issued a warning letter to LNK International for failing to fully investigate contaminated lots of antihistamines it released to the market.

The agency rapped the Hauppauge, New York over-the-counter drug manufacturer for its handling of out-of-specification lots of its diphenhydramine product. Despite confirming the initial OOS results, the company released four lots contaminated with yeast and mold, based on passing results from additional samples.

Following this failure, the company was slow to recall the contaminated lots and to take corrective actions in its manufacturing operation, the agency said. It also failed to ensure that the contamination didn’t affect other lots.

The FDA found the company’s testing deficient as it “often lacked specifications or analytical testing procedures” for dissolution testing and did not test for the impurity 4-Aminophenol in some acetaminophen-containing products.