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Hospira is a drug manufacturer with big problems. It claims it provides “high-quality, lower-cost generic medications”, among other products. In the past year, however, the company has received four warning letters from the FDA. And, within the past several weeks, Hospira “voluntarily” recalled two more drugs, both of which contain strands of glass. According to the company, “glass strands were identified as being affixed to the inside of the vial walls, which had the potential to dislodge into the solution, potentially endangering the patient by inducing vomiting or even embolisms.”
Hospira has a troubling history of problems both in its India plant and the manufacturing facility located in Rocky Mount, NC. In May 2013 The FDA issued a warning letter to the Hospira facility in India referring to unaddressed issues discovered during an inspection in October 2012; included were 6 separate issues relating to sterility practices. The letter noted similar issues were found in a February-March 2013 inspection of the Hospira facility in Rocky Mount, NC.
Looking a little deeper I found a series of recalls on multiple Hospira products, all containing particles or other contaminants. In early March 2013, Hospira recalled lots of five different injectable products. Later that same month, Hospira issued a nationwide recall due to the presence of particles determined to be brass and lead in sodium chloride injections.
In August 2013, there was a recall for a specific lot of Aminosyn after a customer found an unknown particle in the injection, which turned out to be human hair. Two weeks later Hospira had to recall a lot of Lidocaine that was found to contain bits of oxidized stainless steel.
Hospira issued a third recall in August for faulty blood bags due to a design error in “which the outer wall of blood bags were punctured with the piercing pin on certain Hospira blood sets during insertion of the pin into the blood bag.” The U.S. Food and Drug Administration (FDA) characterized the action as Class I recall, necessitating this notice.
At issue here is the continued inability of Hospira to improve its manufacturing conditions. Four warning letters in one year. A plant on foreign soil where the conditions are so bad that the FDA questions whether it uses sterile gloves. Is that “high quality”? It may be “lower cost”, but high quality seems to be in question. According to a Forbes article, in May of 2013 Hospira replaced plant managers at all five of its drug manufacturing facilities. There is new leadership at the top and much energy has, supposedly, been put into fixing the issues. But we have seen at least 3 more issues in August, and this latest problem in October 2013 speaks to the company’s continuing inability to produce sterile products.
This drug manufacturer makes products designed to be injected in humans—contaminated with oxidized steel, glass shards, human hair and other undetermined particles. These problems are potentially harmful and unacceptable under any circumstances. Profits should not overtake this company’s (and others in the news) to produce a safe, useful product. What if only a small percentage of drug defects have been detected from Hospira? Would you want to be one of the recipients of a drug it produced? Hopefully, Hospira will clean up its act, literally and figuratively. Until then, I would hope and pray that I did not receive one of its “high-quality, lower-cost” medications.
The FDA Warning Letter can be found at:
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