Hospira Guilty of Having Foreign Particles in Injectable Medications According to The FDA

FDA cites Hospira for drug manufacturing violations Drugmaker Hospira said Wednesday that it received a warning letter from the (FDA) Food and Drug Administration regarding poor manufacturing quality at one of its facilities in Australia. The FDA inspected Hospira's drug manufacturing building in Mulgrave, a suburb of Melbourne. Hospira manufactures specialty injectable drugs including mitoxantrone at the facility. The FDA wrote that there were “significant violations of current good manufacturing practice regulations for finished pharmaceuticals,” according to a company disclosure. For example, the agency said that it found impurities in the injectable drugs and that it appeared Hospira was unaware of the situation. Lake Forest, Ill.-based Hospira said the warning letter would not halt production or shipment of drugs from the facility, and it “is evaluating what corrective actions may be required.” “The company takes this matter seriously, and intends to respond fully and in a timely manner to the FDA's warning letter,” Hospira said in its filing. Hospira officials were not available for further comment. Hospira does not anticipate the issue will dampen its 2014 financials, but if the FDA demands large-scale changes, it could “be significant to our ongoing business and operations,” Hospira said. Warning letters from the FDA are not entirely uncommon among pharmaceutical companies. To date in 2014, the FDA has issued a dozen warning letters to drugmakers based on manufacturing or product quality concerns. Hospira's specialty injectable drugs were a big driver in the company's improved earnings in the second quarter of this year.

FDA Warns of NuVision Contamination!

Connecticut health care providers are being urged by the FDA to cease using sterile products from NuVision Pharmacy. The FDA discovered poor sterilization practices being used by NuVision Pharmacy during an inspection that took place in April. Due to the findings of the inspection, the FDA has called upon the pharmaceutical manufacturer to issue a recall for all their sterile products that have not yet passed their expiration dates.


The FDA believes the products made by NuVision Pharmacy may be dangerous and defective drugs due to their possible lack of sterility. According to the FDA, if drugs that are marketed as sterile actually contain a microbial contamination, patients who are given the drugs may be at risk of infection, which can be life-threatening in some cases. The drug manufacturer has repeatedly declined to issue a recall for their sterile products.


Since the FDA does not have the authority to demand a recall of products from NuVision Pharmacy, the manufacturer is not required to do so. However, to deal with the issue, the FDA has called upon health care providers to stop using products labeled sterile by the company. So far, NuVision Pharmacy is not aware of any adverse events related to their sterilized products, but they did end up recalling two other drugs earlier in the year due to sterility concerns. Individuals who have been injected with products made by the company should contact their health care provider if they have any concerns.