Martin Avenue Pharmacy is recalling all of its unexpired sterile preparations and stopping production of sterile drugs after FDA investigators discovered contaminated products and evidence of poor quality control.
During a June to July inspection of the compounding pharmacy’s Naperville, Ill., facility, the FDA observed a black particle in a vial of an injectable drug mix containing papaverine and phentolamine.
The agency also found problems with the pharmacy’s procedures designed to prevent microbial contamination. For instance, personnel who produce sterile drug products aren’t monitored for microbial contamination, according to a Form 483 issued July 21.
Martin Avenue also rinses its sterilized glass beakers and stir bars with “purified” water produced from municipal tap water, however the agency hasn’t tested the water to determine its purity, bioburden or pyrogen levels, the FDA said. In addition, the compounder didn’t conduct stability testing on two types of human injectable sterile drugs: hyaluronidase injectable solution and methylcobalamin.
The pharmacy emphasized that it hasn’t received any complaints of patient risks from the recalled products, but noted that if a compounded drug loses sterility it could infect a patient. The company’s non-sterile preparations aren’t affected by the recall.
The pharmacy said it decided to do the recall and cease production out of an “abundance of caution.”
The FDA has stepped up inspections and enforcement actions on compounders after a November 2013 law enhanced its powers over larger pharmacies. Quality experts have said that a barrage of warning letters to compounders has forced the industry to take FDA enforcement more seriously.
Martin Avenue declined to comment further.
Make sure your products are sterile! Help avoid a costly recall by ordering Manufacturing Sterile Products to Meet EU and FDA Guidelines today!