Sterile products from Ranier's Pharmacy in Jeannette deemed unsafe by FDA
A Jeannette pharmaceutical laboratory’s products may be contaminated, according to the U.S. Food and Drug Administration
Ranier’s Compounding Laboratory, also known as Ranier’s Pharmacy and Ranier’s RX Laboratory, did not properly sterilize its environment while making drugs, the FDA warned this week.
There have been no reports of the pharmacy’s medicine harming anyone, but any products coming from the laboratory that are supposed to be sterile should not be used, according to the FDA.
“Health care professionals and veterinarians should immediately check their medical supplies, quarantine any purportedly sterile drug products, and not administer them to patients,” the agency said in a statement. “Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.”
The warning does not apply to products from the pharmacy not labeled as sterile.
The laboratory has had unsterile conditions for more than two years, according to the FDA.
Fran Ranier, owner of the Lowry Avenue pharmacy, declined to comment publicly.
On Facebook, the pharmacy pledged to “work fully and diligently to meet the goals of the FDA and to resume our sterile compounding practice as soon as possible.”
The FDA first noted problems at the laboratory during an inspection in April 2016, when it found “serious deficiencies in your practices for producing sterile drug products, which put patients at risk,” according to a warning letter the agency sent the pharmacy.
The laboratory promised to fix the problem but didn’t take adequate steps to do so, according to the letter, sent in March 2017.
During a follow-up inspection in May, inspectors found residue on an air filter in a sterile area, as well as “visible dirt, stains or residue that are not removed during routine cleaning” on the floor of a clean room, according to the FDA.
Equipment and materials were not properly disinfected, workers didn’t completely cover their hair while working on drugs, and they touched unsanitized surfaces with their gloved hands then returned to work without changing their gloves, the FDA said. The lab didn’t properly monitor the sterility of its operations, the inspection found.
Last month, the FDA urged the pharmacy to recall the affected medicines. The pharmacy promised to do so but so far has not, the agency said.
Jacob Tierney is a Tribune-Review staff writer. You can contact Jacob at 724-836-6646, firstname.lastname@example.org or via Twitter @Soolseem.