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FDA Announces Recall of Injections Made by Hospira Inc.

Dec 10, 2008 | Parker Waichman LLP

The U.S. Food and Drug Administration (FDA) just announced that Hospira, Inc. has issued a voluntary recall of one lot of 20mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP.  The recall has been issued over an incorrect bar code label

The FDA describes Hospira as a global specialty pharmaceutical and medication delivery company.  This recall is a follow-up to a nationwide voluntary recall that was issued September 18 for one lot (lot number 65-620-FW; expiration date May 1, 2010; NDC 0409-7902-09) of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers.  That recall was implemented because some of the drug’s containers may have been incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09).  Incorrect bar coding could lead to a medication error resulting in a wrong drug being delivered to a patient when a bar code system is used to confirm medication.  The FDA notes that potential adverse events related this sort of error include electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia (“pins and needles” sensations), and mental confusion.

The product contains 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride, said the FDA, pointing out that the product name and National Drug Code (NDC) number printed on the container are correct. The affected lot was shipped to U.S. customers between July 2008 and September 2008.  The FDA also noted that no other lots are affected by this recall, Hospira has not received any reports of adverse health events in connection with the recalled lot, and Hospira has identified the root cause of the error and taken action to prevent its recurrence.

The FDA is advising anyone with existing inventory to quarantine the Hospira product immediately and call Hospira Customer Care at 1-877-946-7747 for instructions on how to return the drugs.  Customers with medical questions should contact Hospira Medical Communications at 1-800-615-0187.  Any adverse reactions experienced with these products, and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088; by Fax at 1-800-FDA-0178; by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch website at www.fda.gov/medwatch.

Hospira made news this autumn after serious adverse events prompted the FDA to announce that companies which market unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products.  Hospira was among the group of manufacturers selling unapproved BSSs.


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