FDA (Devices) recall action 99162
The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline Convenience Kits (Suturing Set, Model SUT13710) containing Huons Lidocaine HCL Injection USP are being recalled due to quality issues identified during an FDA manufacturing inspection.
Medline Industries is recalling three arterial access and insertion kits nationwide because they contain lidocaine ampules subject to a quality issue recall by the manufacturer Huons Co., Ltd., identified during an FDA manufacturing inspection.
Medline Industries is recalling Convenience Kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules due to quality issues identified during an FDA manufacturing inspection of the supplier's facility.
Medline is recalling Ophthalmic Pack convenience kits containing Huons Lidocaine HCL Injection due to quality issues identified during an FDA manufacturing inspection. The recall affects 180 kits distributed nationwide.
Medline Industries is recalling three models of circumcision trays containing Lidocaine ampules due to quality issues identified during an FDA inspection of the drug manufacturer.
Medline Industries is recalling convenience kits containing Huons Lidocaine HCL Injection USP 1% ampules due to quality issues identified during an FDA manufacturing inspection of the drug maker's site.
Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% ampules are being recalled due to quality issues identified during an FDA manufacturing inspection. Affected kits have been distributed nationwide.
Medline Industries is recalling 432 L&D Continuous Epidural Tray kits nationwide due to quality issues identified with the included Lidocaine ampules during an FDA manufacturing inspection.
Medline Industries is recalling multiple convenience kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection of Huons Co., Ltd.'s drug manufacturing site.
Medline Industries is recalling 15,662 Convenience Kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection of the drug supplier's facility.
Medline Industries is recalling Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection.
Medline Industries is recalling Imaging Biopsy Tray and Breast Biopsy Pack kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection.
Medline Industries is recalling two convenience kits (Arterial Line Kit and Ultrasound Guided IV Securement Set) due to quality issues with included Lidocaine Ampules identified during an FDA inspection.
Medline Industries is recalling 1,512 Convenience Kits nationwide that contain Lidocaine HCL Injection USP ampules due to quality issues identified during an FDA manufacturing inspection of the supplier's facility.
Medline Industries is recalling three convenience kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection of Huons' facility.