Visible Particulates Prompt Another Hospira Recal
Injectables giant Hospira has initiated its second nationwide recall in as many months due to a glass supplier issue that resulted in the presence of particulates.
The recall of a single lot of Lidocaine HCI Injection, USP, 2%, 20 mg per mL single-dose vial, preservative-free, stemmed from a customer report of a discolored product with visible particles, as well as particulates embedded in the molded glass container, the company said.
As with its June recall, Hospira attributes the particulates to a glass defect and says it’s working with the supplier on corrective and preventive actions. Hospira declined to comment on whether the same supplier was at issue behind both recalls.
An undetected particulate could block administration of the drug to the patient, causing a delay in therapy, Hospira said, adding that this is unlikely due to the size of the particulates identified. It is more likely that particulates would move through the catheter and result in local inflammation, mechanical disruption of tissue or immune response, said the company, identifying the particles as iron oxide.
In the rare event that a particulate is exposed to a strong magnetic field, such as an MRI scan, it could dislodge and cause tissue damage, Hospira said, again adding that this is unlikely due to their small size.
Hospira said it hasn’t received any adverse event reports related to the product. The recalled lot was distributed nationwide from June 2013 through July 2013.
This is just the latest in a string of recalls that have dogged the company recently. In July, the drugmaker was forced to recall a lot of lactated ringers and dextrose injection due to mold found by a customer. In June, it pulled a lot of Marcaine painkiller due to particulates, as well as its heart disease drug dobutamine over discoloration in a single vial. This April, the drugmaker was forced to recall one lot of Marcaine and seven lots of propofol.
In November 2013, the company landed a Form 483 for glass particles found in sterile lyophilized drugs during an inspection of the company’s McPherson, Kan., plant.
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