Spectra Medical Devices, Llc — Class II: Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectr
Spectra Medical Devices, LLC is conducting a Class II voluntary recall of Lidocaine HCl Injection USP (25x5 mL Single-Dose Ampules) due to a lack of assurance of sterility.
This affects Spectra Medical Devices, LLC, healthcare facilities using NDC 65282-1605-1, and personnel involved in the procurement and quality oversight of sterile injectable narcotics or anesthetics.
A Class II recall due to sterility concerns suggests a breakdown in aseptic processing or environmental controls during manufacturing. This indicates potential systemic issues in the quality agreement or oversight between the U.S. distributor and the South Korean manufacturer, necessitating a review of sterilization validation protocols and batch record documentation.
Verify current inventory for NDC 65282-1605-1. Conduct an immediate audit of sterile processing validation and environmental monitoring data for current lots of injectable products sourced from international manufacturing partners.
Class II. Reason: Lack of Assurance of Sterility. Product: Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.. Firm: Spectra Medical Devices, Llc (Wilmington MA United States). Status: Ongoing.
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