The voluntary recall of one lot of its 0.9% sodium chloride injection, USP, 1000 mL, came after a customer found brass particulate in the primary container. The company also announced the recall of two lots of its diazepam injection after customer reports said a loose crimp or no crimp was applied to the fliptop vial and/or the fliptop vial was leaking around the collar when inverted.
The company said it has not received any reports of adverse events for either injection and it is investigating the root cause of the contamination.
The particulate in the sodium chloride injection was identified as containing copper, zinc and lead, according to the US FDA (Food and Drug Administration). If administered, solution containing brass particulate may result in occlusion of small blood vessels, according to the FDA. Copper toxicity may result in a worst case scenario, resulting in possible fatal hepatic necrosis, the FDA added.
The sodium chloride injection was distributed between January 2013 and March 2013 to wholesalers/distributors, hospitals and pharmacies nationwide. "Regarding where the product is made, Hospira doesn't typically disclose the manufacturing location of individual products," Hospira spokesman Tareta Adams told Outsourcing-Pharma.com.
The diazepam lots were distributed from October 2012 through December 2012.
In addition, the company also recently announced it was expanding its February 26, 2013 recall of sodium acetate injections to include two more lots. The additional lots, distributed from January through February 2013, are being recalled after customers said no crimp was applied to the fliptop vial. The recall is a precautionary measure, Hospira said.
The issue of missing crimps cropped up in recalls of multiple lots of five different injections in late February. Another lot of the same sodium chloride injection was recalled for being incorrectly released without meeting product specifications, according to the announcement.
The recalls were related to faulty packaging and “visible particles embedded in the glass identified during a retain sample.”
The numerous recalls over the last few months come as the FDA has recently completed it re-inspection of the company’s Rocky Mount, NC, manufacturing facility and issued another Form 483.
The facility was cited with 20 violations, three of which were repeat observations, Hospira said in an SEC filing. The company pledged last year to invest $85m in the site and add 200 more jobs there but a response on how this plan will transpire following the 483 was not received by press time.
The warnings also follow similar 483s issued at the company’s facilities in Colorado and Austin, Texas, as well as one for its Lake Forest, Illinois device plant. The company’s other device plant in Costa Rica was hit last year with an import ban on several devices, furthering the company’s troubles.
The remediation efforts to fix these issues are pegged at about $375m, but that figure was largely dependent on how harsh the violations are for the Rocky Mount plant.
Possible Consent Decree
Several Wall Street analysts have said Hospira may have to enter into a consent decree with the FDA because of the nature and frequency of the recalls and manufacturing violations at its plants.
“I was always told it would take a while, because Hospira is complicated and functions across different FDA divisions,” RBC analyst Shibani Malhotra said. “And so, everyone at the agency needs to be aligned for a consent decree. With the import ban from Costa Rica, the Austin 483, the Lake Forest 483 and now the Rocky Mount one, I cant see how the agency won't act."