Hospira recalls 5 lots of injectable drugs over sterility concerns
- Manufacturing problems continue to bedevil Pfizer subsidiary Hospira, Inc., which last week announced it would voluntarily recall one lot of an injectable pain medication and four lots of the blood pressure medicine Levophed due to concerns over sterility.
- In a notice posted by the Food and Drug Administration, Hospira said use of a damaged sterilizing filter for nitrogen during the manufacturing process for the drugs could have compromised sterility assurance.
- The product lots in question were distributed throughout the U.S, Singapore and Taiwan between May and July. No reports of adverse events have emerged, however, and no microbial contamination has been detected.
Recalls and manufacturing violations have shadowed Hospira, which Pfizer acquired back in 2015 only to inherit a chain of legacy compliance issues.
In June, Hospira voluntarily recalled dozens of lots of sodium bicarbonate as well as several other drugs — also due to concerns over sterility assurance. The recall exacerbated an ongoing shortage of sodium bicarbonate, commonly used by hospitals for patients whose blood has become too acidic.
Those recalls came in the context of ongoing compliance issues at Hospira facilities. The Food and Drug Administration in March flagged a plant in McPherson, Kansas for violations of good manufacturing practice (GMP) standards, continuing a string of issues that Pfizer believes it is slowly solving.
Four other Hospira sites had been cited by the FDA in inspections prior to Pfizer's takeover of the company.
While this latest recall doesn't appear to have had any medical impacts so far, it puts pressure on Hospira, which manufactures for both Pfizer and third parties to improve its quality assurance.
The affected product lots:
Pfizer said an investigation to determine root cause is under way and has initiated corrective and preventive actions.
- Food and Drug Administration Recall notice
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