Hospira in major US ketorolac recall
pharmafile | August 4, 2015 | News story | |Â Â Â
Hospira is being dogged with manufacturing problems that have led to the recall of millions of vials of its painkilling drug ketorolac in the United States.
The production issues that have cropped up have led Hospira to recall more than 20.7 million more vials of ketorolac, a drug on the FDA shortage list, in the US.
According to the most recent FDA Enforcement Report, Hospira is recalling 15.5 million vials of ketorolac tromethamine 30 milligrams, of which about 12.5 million vials have the Hospira label and more than 3 million vials were produced by Hospira for Novaplus.
It also is recalling 5.5 million 60 mg vials – more than 5.2 million with the Hospira label and 250,600 with the Novaplus label.
This is not the first time Hospira has been beset by manufacturing and production problems that have led to products being recalled. Hospira issued a recall of the anaesthetic propofol in February, after the neck of one vial was revealed to contain traces of iron. And in October 2014 the firm issued a recall of its injectable vancomycin hydrochloride in the US due to ‘uncontrolled storage during transit’.
Hospira has blamed the latest blunder on the crystallisation of calcium salt in batches of ketorolac, a non-steroidal anti-inflammatory drug (NSAID) used for the short-term relief of moderately severe pain. On a smaller scale, Hospira has also recalled another drug on the national shortage list – some 314,600 bags of 0.9% sodium chloride because of suspected leaky bags.
In a statement Hospira says it “remains committed to the highest standards of product and manufacturing quality, and takes very seriously our responsibility to ensure we follow regulations and company operating procedures.”
It adds: “In the last few years, Hospira has invested more than $1 billion across the company to help ensure high-quality products are available to patients in sustainable supply. We are proud of our progress, but our work is not done. We remain dedicated and focused across our global network to ensure that we are meeting all the requirements of global regulatory bodies, and executing on the commitments that we have made to ensure sustainable compliance across our entire manufacturing footprint.”
The Hospira recalls come as the FDA’s Center for Drug Evaluation and Research published guidance for consultation with pharma companies, on how to avoid manufacturing issues that lead to faulty drug batches and drug shortages.
The FDA will work with drug manufacturers to produce quality metrics, to encourage better standards and which could lead to a risk-based approach to scheduling inspections. Those who perform well on the benchmarks could be inspected less frequently, while those who fail to meet the metrics would be identified as risky and potentially inspected by regulators more often.
Lilian Anekwe
