Hospira, Inc. announced it has initiated a voluntary nationwide recall of one
lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 20 mL Multiple-dose
FliptopVial, NDC 0409-4276-01 Lot 25-090-DK (the lot number may be
followed by 01 or 02). This action is due to one confirmed customer report of
visible particulate,identified in the primary container, in the form of
dark red/black particles. The particulate was identified as oxidized stainless
steel. Depending on the particlesize, if undetected, it could block
administration of the drug to the patient, causing a delay in therapy. Impact
to the patient would depend on the time it would taketo obtain a new
vial, the condition being treated and the patient’s status.
BACKGROUND: The recall is being conducted as a precautionary
measure. The root cause has not been determined and is under investigation.
Hospira informed customers ofthe issue in a letter dated Sept. 16, 2013.
This lot was distributed March 2013 through June 2013.
RECOMMENDATION: Anyone with an existing inventory should stop use and
distribution, quarantine the product immediately, and call Stericycle at
1-866-364-8812 betweenthe hours of 8am to 5pm ET, Monday through Friday,
to arrange for the return of the product. Replacement product from other lots
Healthcare professionals and patients are encouraged to
report adverse events or side effects related to the use of these products to
the FDA's MedWatch SafetyInformation and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form,
then complete and return to the address on the pre-addressed form, or
submit by fax to 1-800-FDA-0178
MedWatch Safety Alert, including links to the Firm Press Release HERE.
Source: U.S. Food and Drug
Administration (FDA) (Accessed: 10/5/2013)