Company Issues Voluntary Drug Recall for Non-Expired Sterile Injectable Drugs
On Wednesday, July 23rd, the FDA and Unique Pharmaceuticals announced a voluntary drug recall on behalf of the pharmaceutical manufacturer for all non-expired sterile injectable drugs.
Unique Pharmaceuticals manufactured the products for sterile use in Temple, Texas, and most of the labels feature the code “Temple TX USA 76502.”
“The recalled products include Lot 86513, N-Acetyl Cysteine 20%, and all other non-expired, purportedly sterile drug products,” the agency said in a statement posted on its Web site.
According to the FDA, two recent inspections of the facility revealed insanity conditions that would compromise the sterility of the drugs. There were recurring environmental problems at the facility, as well as contamination problems, and poor sterility practices, which led to the drug recall. On July 11th, the FDA sent a request for the company to issue a formal drug recall, and cease sterile compounding operations, and the company complied.
“These inspections revealed sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices,” the agency said.
“Using these products puts patients at an unacceptable risk for serious infection,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We urge health care professionals to follow recall instructions issued by the firm.”
Unique Pharmaceuticals is the latest in a long line of compounding pharmacies that have come under fire for unsanitary conditions. While the company did comply with the FDA and issue a voluntary drug recall, the FDA’s ability to regulate compounding pharmacies on behalf of consumers is a recent phenomenon.
Drug Compounding Pharmacy Bill Signed Into Law in November 2013
On Wednesday, November 27th, President Obama signed a bill aimed to regulate drug compounding pharmacies into law.
The bill passed the House and the Senate without opposition on Monday, November 18th, and was signed into law by the president the following week.
The new bill – the Drug Quality and Security Act – requires compounding pharmacies that wish to produce large batches of drugs for mass consumption to register with the FDA, like other pharmaceutical manufacturers, so they will be subject to the same sort of inspections and oversight. Compounding pharmacies that do not wish to make this change are unable to make large batches of drugs, and are required to stick to the original definition of “compounding,” meaning they will tailor-make drugs for specific prescriptions. Although these compounding pharmacies will not be required to meet traditional FDA drug regulations, they will be required to open their books to the FDA when the agency receives complaints.
Originally, compounding pharmacies were subject to state regulations, but federal agencies like the FDA, CDC, and USDA had almost no control over them. They were not required to report problems with illnesses, unlike other pharmaceutical manufacturers.
Within 4 years, drugmakers and compounders will be required to put serial numbers on all drug packages, and in 10 years, the industry must upgrade to electronic codes. These measures will make it easier for the FDA to regulate drug compounding pharmacies, and track problems that occur in the substances.
The Strom Law Firm Can Help with Personal Injury Claims from Dangerous Drug Recalls
If you or a loved one have been injured, harmed, or killed by a medical product such as a drug or device, from medical device manufacturers or compounding pharmacies, you may be entitled to file a personal injury lawsuit. Defective medical devices and dangerous drugs can hurt you to such a great extent that you are unable to work, with mounting medical bills The attorneys at the Strom Law Firm can help get you the compensation you deserve, to get you through these tough times. We are licensed to practice across South Carolina, Georgia, and New York. To help you with your case, we offer free, confidential consultations. Do not hesitate to contact us. 803.252.4800