Pennsylvania Manufacturer Called Out for Contamination

The FDA cited Genus Lifesciences for production failures and handling of contaminated oral solution drug products.

Following a July 16-20 inspection of the drugmaker’s Allentown, Pa., facility, the FDA noted that the firm had received four consumer complaints in the past two years about the presence of mold or a black substance within the closure and around the bottle top of its oral finished drug products. Three of the complaints involved bottles of the firm’s oxycodone hydrochloride oral solution; the fourth concerned a bottle of its potassium chloride oral solution.

Two of the four batches were confirmed to be out-of-specification for micro testing — but no testing was performed to track down the source of the black substance or the contamination and the lots remained on the market until they expired.