Hospira Initiates Voluntary Recall of One Lot of Lidocaine and Certain Lots of LifeCare IV SolutionsBy
Hospira Inc. said it will initiate a voluntary recall of one lot of 1% lidocaine HCI for Injection, USP, 10 mg per mL, 30-mL single-dose, preservative-free (NDC 0409-4279-02; Lot 40-316-DK, Expiry April 1, 2016) to the user level due to a confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, embedded in and attached to a pinched area of the stopper. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.
This lot was distributed nationwide from May 2014 through June 2014. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
In a separate action, Hospira has also announced the voluntary recall of certain lots of several products in its LifeCare line of flexible intravenous solutions due to the potential for leakage. The issue, which Hospira notified customers about in a Dear Health Care Provider letter issued earlier this year, was identified during re-inspection of a manufactured product lot in which a single puncture mark was identified going through the overwrap and primary container.
The puncture in the primary container may result in leakage that is difficult to detect. Leakage may result in an open system, which has the potential for contamination, compromised sterility, drug waste, spillage, inadequate or inconsistent solution/medication dosing, and/or delay in therapy, all of which may require medical intervention and should be reported to Hospira and/or the US Food and Drug Administration (FDA). Hazardous topical exposure may occur if a hazardous drug is added to the flexible container. Hospira's product insert packaged with LifeCare flexible intravenous containers recommends providers do not administer unless the solution is clear and the container is undamaged.
The root cause is attributed to a defect in a conveyance system, and corrective actions have since been implemented to prevent a reoccurrence. To date there have been no reports of adverse events associated with this issue for the impacted lots. The manufacturing issue that caused this incident has been addressed. The affected lots were originally distributed by Hospira to direct accounts from September 2013 through October 2014.
Source: FDA/Hospirea (lidocaine) and FDA/Hospira (LifeCare)