Asclemed USA Inc. — Class II: Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampu
Asclemed USA Inc. has initiated a Class II recall for Accucaine kits containing Lidocaine HCl Injection USP 1% due to a lack of assurance of sterility. The recall is currently classified as ongoing and involves product distributed by Enovachem Pharmaceuticals.
This recall affects Asclemed USA Inc., Enovachem Pharmaceuticals, and healthcare facilities or clinical sites utilizing Accucaine kits (NDC 76420-715-01) for local anesthesia.
A Class II recall due to sterility assurance concerns suggests a failure in aseptic processing or environmental monitoring that, while not likely to cause serious adverse health consequences, presents a remote possibility of infection or contamination. Regulatory and QA teams may view this as a trigger to audit the primary manufacturer’s sterilization validation and supply chain oversight, as the kit contains components from multiple sources.
Quality and clinical teams should verify inventory for the specified NDC, quarantine affected kits immediately, and evaluate potential supply disruptions for local anesthetic procedures if this kit is a primary component of their formulary.
Class II. Reason: Lack of Assurance of Sterility. Product: Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.. Firm: Asclemed USA Inc. (Torrance CA United States). Status: Ongoing.
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