Alcohol wipes which allegedly killed a 2-year-old child may be a factor in federal regulators ceasing production of all drug products by H&P Industries, a manufacturer of medical products under the name Triad Group.
The company shut down Monday pursuant to an FDA request.
Triad was sued by a Texas couple who blame it for the death of their 2-year-old son.
In the lawsuit, Shanoop and Sandra Kothari maintain an alcohol wipe made by Triad Group Inc. was the probable source of a bacterial infection that killed their son, Harry, a few months ago.
Subsequent to this death, FDA posted a notice that Triad was issuing an urgent recall of all lots of its swabs and wipes because the products might have been contaminated with the bacteria Bacillus cereus.
An FDA inspection report recently revealed numerous issues at the Triad plant, including employees packing acne pads into product containers with their bare hands and children's multi-symptom cold medicine made without a necessary active ingredient.
"Employees engaged in the processing and holding of a drug product lack the education required to perform their assigned functions," the FDA wrote in its 30-page report.
Inspectors also said they found examples of equipment and utensils not cleaned, maintained and sanitized at appropriate levels to prevent contamination that would alter the safety, identity, strength, quality or purity of a drug product.
"We have asked (Triad) to cease production and distribution of all their drug products," FDA spokeswoman Shelly Burgess said yesterday.
The company said the bacteria could lead to life-threatening infections in at-risk populations, including surgical and immune-suppressed patients. The recall, according to the company, was being done out of an "abundance of caution" and was not linked to an illness or death.
Triad has since recalled other products and shut down some production lines.
Tuesday, a Colorado hospital said it confirmed that two-thirds of the Triad-made alcohol prep pads it tested were contaminated with Bacillus cereus.
Children's Hospital, of Aurora, Colo., became concerned after two patients acquired infections. The hospital found Bacillus cereus in the alcohol prep pads, which are routinely used in surgery.
"This told us that we had a product that was contaminated, but we don't have a direct match between the product and the patients," said Susan Dolan, hospital epidemiologist, adding that tests were inconclusive.
The company said that it will meet with regulators soon, and that it has taken aggressive action to resolve issues.
"We issued voluntary recalls as precautionary steps, shut down many production lines, responded to all observations noted by the FDA during inspections, reviewed our overall operations, and laid out a series of other actions in a detailed plan and timeline for corrective actions," H&P Industries said.
It's unusual for a company not to comply with an FDA voluntary request to cease production, since the next action could be a court injunction that orders a shutdown.
Most companies would stop, said Mark Kramer, president of Regulatory Strategies Inc., in Fox Point.
"Even if a company strongly disagreed with an FDA request, they would likely comply and then would do whatever it takes to convince the agency they were wrong, or they would make the necessary corrections to have the request lifted," Kramer said.