Hospira is voluntarily recalling 181,704 bags of magnesium sulfate in 5% dextrose injections because labels on the immediate container may have barcodes indicating that it is instead the blood thinner heparin.
The Department of Homeland Security warned that due to a cybersecurity flaw, a low-skilled remote hacker could alter the configurations of Hospira's LifeCare PCA Infusion System.
Just weeks before announcing that it was selling itself to Pfizer for $15 billion, Hospira said it had decided to close up its once-troubled plant in Clayton, NC, and lay off the 250 workers in June. Those job cuts have now begun.
Hospira has worked itself out from under the warning letters for its pharma manufacturing plants in Rocky Mount and Clayton, NC. That means that Pfizer, which is buying Hospira in a $17 billion deal, will not have that hanging over its head, although the company still has plenty of other regulatory issues with which Pfizer will have to contend.
Injectable drug specialist Hospira, which is being bought by Pfizer, blew past analysts' projections for its Q1 earnings today, but its manufacturing issues continue to be a drag. Just last week, the FDA said Hospira had issued a recall of an anesthetic because iron particles had been found in some vials.
When Pfizer announced its $15 billion deal to buy sterile injectable specialist Hospira, execs said they had studied FDA concerns over Hospira manufacturing before pulling the trigger. But Hospira just keeps giving Pfizer new lessons. Today, the FDA posted a warning letter it recently sent to Hospira CEO F. Michael Ball for a plant in Italy.
Hospira has just picked up an FDA warning letter for a plant in Italy, meaning it now has plants tagged with warning letters on four of the 7 continents: Europe, North America, Asia and Australia. But the problem will be Pfizer's to deal with since it has struck a $15 billion deal to buy the sterile injectable specialist.
Hospira has initiated not one, but two, more recalls of injected drugs already on the FDA drug shortage list. One is saline solution and is being recalled after a human hair was found in a delivery bag. This is the second time this has happened since the first of the year.
Several factors in the manufacturing process can lead to a drug shortage. Now, the FDA has launched an effort to combat the effects of such shortages, bringing the battle to your smartphone.
The opening of Hospira's new plant in India that it is counting on to lower its manufacturing costs will be delayed again after it racked up another set of observations during a reinspection by the FDA last month. Unless quickly resolved, it will be an issue that Pfizer will inherit given its $15 billion buyout of Hospira announced last month.