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Clinical Updates — Clinical Updates

LifeCare Flexible Intravenous Solutions by Hospira, Inc. Recalls Lots Containing Sodium Chloride and Dextrose Injection Solutions

The US Food and Drug Administration (FDA) has alerted health care providers that Hospira, Inc. (Lake Forest, IL) has announced the voluntary recall of certain lots products in its LifeCare line of flexible intravenous solutions. The recall, due to the potential for leakage, includes sodium chloride and dextrose injection solutions.

According to the FDA, the issue was identified during re-inspection of a manufactured product lot in which a single puncture mark was discovered to have gone through the overwrap and primary container. This puncture in the primary container may result in leakage that is difficult to detect. The cause is attributed to a defect in a conveyance system, and corrective actions have been implemented to prevent reoccurrence.

According to Hospira, to date there have been no reports of adverse events associated with the recalled lots.

Hospira distributed affected lots to direct accounts from September 2013 through October 2014. Following is a list of the recalled lots containing sodium chloride and dextrose. See the pharmacy’s news release for the full list of products.

If you have any of the recalled lots, you should stop use and distribution and quarantine the product immediately. Hospira will notify its direct customers via a recall letter and will arrange for the recalled product to be returned to Stericycle.

To return products, or for additional assistance, call Stericycle at 1-844-861-6221 Monday through Friday from 8:00 AM to 5:00 PM (EDT).

To report an adverse event or side effect:

• Complete the online MedWatch Voluntary Reporting Form.

• Download the form or call 800-332-1088 to request the reporting form. Complete and return it to the address on the form, or fax to 800-FDA-0178. 

• Complete the ASRS Adverse Event Report Form.
    

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Published October 2014