July 30, 2014 — Hospira Inc. has issued a recall for one lot of Lidocaine HCl due to the risk of contamination. No adverse events have been reported and Hospira believes the risk of adverse events is “extremely unlikely.”
Recalled product description:
- Lidocaine HCI Injection: USP, 2%, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD) Expiration: January 1, 2015. Product is packaged 10 units per carton / 180 units per case. The recalled lot was distributed from June 2013 through July 2013.
Lidocaine, also known as “Xylocaine,” is a common local anesthetic that is used in different parts of the body to cause numbness or a loss of feeling in patients undergoing certain types of medical procedures.
The recall was issued after Hospira confirmed a customer report of a discolored product with visible particles in the solution as well as particulate embedded in the molded glass container. The contaminant was identified as iron oxide. Hospira blames the problem on a supplier’s glass defect.
The contaminated injection could cause a variety of adverse events. If the particle was large, it could block administration of the drug to a patient and cause a delay in therapy. However, this is unlikely because the particles observed were too small.
It is more likely that small particles will pass through the catheter and cause local inflammation, mechanical disruption of tissue, or an immune response. In extremely rare cases, it is possible that the particle could dislodge and cause tissue damage if exposed to a strong magnetic field (e.g., MRI).
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