Hospira announced a voluntary nationwide recall of one lot of Lidocaine HCl Injection (10mg/mL) 1% due to a confirmed report of dark red/black particles identified in the primary container. The particles have been identified as oxidized stainless steel.
Lidocaine HCl is a local anesthetic indicated for local or regional anesthesia for infiltration and nerve block. Administration of the particles can potentially block drug delivery to the patient, causing a delay in therapy.
The affected product has Lot #25-090-DK (may be followed by “01” or “02”), NDC 0409-4276-01, and is supplied in a 20mL Multiple-dose Fliptop Vial.
Hospira informed customers in a letter dated September 16, 2013. Replacement product from other lots is available and customers are to call (866) 364-8812 to arrange for return of the product.
For more information call (866) 364-8812 or visit the FDA MedWatch page.