Hospira Issues Voluntary Recall of One Lot of 20meq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Due to Incorrect Bar Code Label
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Date of Recall:
Monday, December 8th, 2008
Recall Details:
LAKE FOREST, Ill., Dec. 8, 2008
-- Hospira, Inc., a global specialty pharmaceutical and medication
delivery company, is following up on a nationwide voluntary recall issued
Sept. 18 of 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 because a small
number of the containers may be incorrectly labeled with a bar code for 5%
Dextrose Injection, USP (NDC 0409-7922-09). The incorrect bar code could lead
to a medication error resulting in the wrong drug being delivered to a patient
if a bar code system is used to confirm the medication. Potential adverse events
related to an error of this type include electrolyte imbalance, cardiac dysfunction,
gastrointestinal disturbances, paresthesia and mental confusion.
The product contains 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium
Chloride. 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. No other lots are affected by this recall.
Hospira has not received any reports of adverse health events in connection
with the recalled lot. Hospira has identified the root cause of the error and
taken action to prevent its recurrence.
Anyone with an existing inventory should quarantine the product immediately
and call Hospira Customer Care at 1-877-946-7747 for instructions on how to
return it. Customers who have medical questions should contact Hospira Medical
Communications at 1-800-615-0187. This recall is being conducted with the knowledge
of the U.S. Food and Drug Administration (FDA).
Any adverse reactions experienced with the use of 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.
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