Drug recall lawyers at Pintas & Mullins Law Firm confirm that Hospira Inc. recently announced a recall of three lots of injectable drugs due to glass contamination. The company stated that the strands of glass could dislodge and harm patients if injected, and blamed one of its suppliers for the defects.
The glass particles can detach from the inner walls of vials and be injected into patients, causing injuries such as vein inflammation. Fragments may also cause extensive organ damage by blocking vein blood flow in vulnerable patients, such as the very young, very old, and anyone with blocked arteries or vascular diseases.
The recalled lots were manufactured and shipped between June and September 2013, to pharmacies, wholesalers, and hospitals throughout the U.S. Fortunately, no injuries have yet been reported to Hospira or the FDA. The pharmaceutical giant stated that it was currently working with the responsible supplier to implement corrective and preventative measures.
The recalled drugs are intended to treat gastrointestinal problems (drug name metoclopramide) and nausea in cancer patients (ondansetron). This is about the fifth recall Hospira has initiated just this year: the most recent occurred in August 2013 when the company recalled an amino acid solution when a patient found a human hair in a vial.
In May and several times before that, Hospira came under fire by federal agencies for unsanitary conditions at one of its manufacturing facilities in India. Employees at that plant reportedly failed to clean surfaces and used damaged gloves during production of sterile injectable drugs.
Previously, though still in 2013, FDA inspectors discovered similar quality-control issues at a Hospira facility in North Carolina. Two years before this, at the same North Carolina facility, FDA inspectors cited Hospira for failing to fix defective equipment and other comparable problems, such as inadequate recordkeeping and unsatisfactory purity safeguards.
Hospira’s manufacturing problems are not exclusive to its pharmaceuticals, unfortunately. In February of this year, FDA inspectors cited several quality control violations in its medical device reporting and complaint system. Companies that manufacture and sell medical devices or drugs are required to have working, efficient and comprehensive programs to monitor customer feedback and adverse event reports.
These operational shortcomings were actually repeat violations from FDA inspections in 2012, signaling the company’s reluctance to adhere to federal standards for customer care. The FDA sent a letter to Hospira in August 2013 regarding yet another of its manufacturing plants, this one located in Costa Rica. That letter informed Hospira that there were several quality control issues at the facility, at which most of its infusion devices and sets and produced.
Next on the list of federal woes, in July 2013, the company recalled several
shipments of four injectable cancer drugs after flaws were discovered
in the glass vials (similar to this most recent recall). Since the drugs
are injected directly into the bloodstream, flaws of this kind could cause
serious injury and are wholly unacceptable.
Hospira attorneys at Pintas & Mullins Law Firm encourage anyone who regularly received drugs from Hospira or is implanted with or uses its medical devices to stay up-to-date with all recalls, FDA alerts, and warning letters issued. We will continue to report on Hospira’s quality control issues as new reports emerge.
If you or a loved one was seriously injured by a recalled or contaminated pharmaceutical or medical device, you have important legal rights, and may be entitled to significant compensation for your medical bills and lost wages. Our attorneys offer free, no-obligation legal advice to injured patients nationwide.