JCB Laboratories Recalls Sterile Drug Products

Compounding pharmacy lawyers at Pintas & Mullins Law Firm announce that JCB Laboratories recently issued a recall of several lots of its sterile drug products due to microbial contamination. Among the affected medications include sodium thiosulfate, sodium citrate, and acetylcysteine.

All six lots of recalled products were distributed to outpatient dialysis clinics in several states, between July and August 2013. In its efforts to step up quality control measures, the FDA inspected the lab JCB uses for testing, Front Range Laboratories, and observed that Front Range’s sterility measures were not reliable.

JCB, along with more than 100 other compounding pharmacies, used Colorado’s Front Range to verify drugs’ sterility, quality, and expiration dating. During inspections the FDA observed several problems with the lab’s sterility, strengths, and stability qualities, which may have resulted in pharmacies receiving inaccurate test results. The agency is currently recommending that pharmacies not use Front Range for quality attributes until reliability can be restored.

JCB is notifying its patient customers of the recall via phone, email, fax and mail. Anyone in possession of an affected product should contact JCB Labs at 316.773.0405 for assistance returning it. Any health issues or concerns that arose after taking a recalled medication should be reported to the FDA’s MedWatch program.

A similar recall was issued just a few days ago, in August 2013, by compounding pharmacy Dr. Reddy’s Laboratories. The company recalled five lots of Ranitidine Hydrochloride tablets, which are taken to treat gastric problems, such as ulcers and Zollinger-Ellison syndrome. The recalled lots were microbial contaminated, and supplied to three separate parties without labels so those parties could market the drug using their own label designs.

Walgreens sold the product under the Wal-Zan label, Supervalu under the Equaline label, and Walmart under the White Equate brand (Acid Reducer). When tested, one lot of raw Ranitidine Hydrocloride tested positive for Pseudomonas sp., which is an aerobic bacteria and can cause various human diseases.

Though compounding pharmacies have been subject to significantly heightened scrutiny after the fungal meningitis outbreak in late 2012, big pharma corporations such as Johnson & Johnson still continue to sicken patients throughout the country. Just last month, J&J agreed to pay nearly $23 million to settle a lawsuit over its quality control measures.

The plaintiffs, a group of investors, claimed the company concealed important quality failures which directly led to a major recall of children’s medications in 2010. The recall affected about 40 nonprescription drug products, such as Children’s Tylenol, in the largest recall of children’s medicine in the FDA’s history.

In inspections, the FDA found multiple problems at J&J plants in Pennsylvania, including bacterial contaminations and unclean equipment. The facility was later shut down, however, the company faced a mountain of litigation from the problems. Shareholders of J&J felt that the company was skimping on quality control measures and knowingly concealed this to them and the public, prompting them to file a class action suit.

Plaintiffs also alleged that J&J attempted to skirt any negative publicity from the recalls by concealing facts about the FDA inspections and orchestrating a “phantom recall” of Motrin products, according to Reuters. The company also recently recalled the popular anti-fungal treatment, Nizoral (ketoconazole), due to reports of severe liver injures and adrenal gland problems. Nizoral may also interact with other medications, causing dangerous side effects.

Americans consume more than $300 billion worth of medications every year, by far the most of any pharmaceutical market in the world. Dangerous drug lawyers at Pintas & Mullins Law Firm have decades of experience advocating on behalf of those seriously injured by recalled, defective, or exceedingly dangerous medications. If you or a loved one was significantly injured or sickened by a pharmaceutical, our attorneys are here to help and are available to talk with potential clients from all 50 states for free legal evaluations.