Lidocaine Recall by Hospira | Dr. Justine Lee

Posted by justinelee in Blog, Recalls

Hospira Announces Voluntary Nationwide Recall Of One Lot Of Lidocaine HCI Injection, USP, 2%, 20 mg per mL Single-dose Vial, Preservative-free, Due To Particulate Matter

If the particulate goes undetected and solution is administered – depending on the particle size and number – it could block administration of the drug to the patient, causing a delay in therapy. However, this is an unlikely outcome due to the size of the subvisible particulates identified. It is more likely that particulates are able to pass through the catheter and may result in local inflammation, mechanical disruption of tissue or immune response to the particulate.

While extremely rare, particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage. However, the particulate size identified is considered too small. Therefore, an adverse outcome is extremely unlikely.

Lidocaine is packaged 10 units per carton / 180 units per case in single-dose glass fliptop vials. This lot was distributed nationwide to distributors/wholesalers, hospitals and clinics from June 2013 through July 2013.

Anyone with existing inventory should immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for returns processing. For additional assistance, call Stericycle at1-855-827-6586 (M-F, 8 a.m. – 5 p.m. ET).

For clinical inquiries, please contact Hospira using the information provided below.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.