July 30, 2014 — The U.S. Food and Drug Administration (FDA) has announced a recall for one lot of Hospira Inc.’s Lidocaine HCl because it may be contaminated with particles of iron oxide.
Lidocaine (also known as “Xylocaine”) is one of the most commonly-used anesthetics. It is injected into patients undergoing certain medical procedures to reduce the sensation of pain.
Description of the recalled products:
- 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.
Hospira initiated the recall after confirming a customer complaint about a discolored solution. There visible particles floating in the solution as well as particles embedded in the glass vial. The particles were identified as iron oxide.The problem was traced to a manufacturer that supplies glass vials for Hospira.
Safety Risks
Hospira says it is “extremely unlikely” that the contamination will cause an adverse event. If the particle is large, it could clog the catheter and delay therapy. This is unlikely because the observed particles were very small. It is more likely that the particles will pass through the catheter to a patient and cause local inflammation, mechanical disruption of tissue, or immune reactions. In extremely rare cases, exposure to a strong magnetic field (e.g. MRI) could result in tissue damage.
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