For the second time in the past few months, the FDA has criticized manufacturer Johnson & Johnson for quality control oversights after several medications were produced with “known contamination with gram negative organisms” in a Pennsylvania factory.
43 products were recalled last week including varieties of Tylenol, Motrin, Zyrtec and Benadryl for infants and children. ABC News describes the nature of the contaminants found in the finished lots of the products:
Preliminary tests have only narrowed down the possible bacterial contaminant to a category of microorganism described as “gram negative,” a broad group that includes many germs potentially harmful to humans.
Although no injuries or illness has been reported stemming from use of the contaminated drugs, consumers report a lax attitude from Johnson & Johnson regarding refunds for the products. And bacterial contamination is not the only quality control issue uncovered at the plant- the drug maker has also come under fire for unsanitary conditions at the factory. The FDA recorded “20 observations of shortcomings” at the facility, which has been shut down indefinitely. The FDA has also not ruled out further action against the company.