Lidocaine Ointment USP
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01.
Compare with the code on your package — it is the most precise check available.
Drug: Lidocaine
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Lidolog Kit lidocaine, kenalog, povidone iodine NDC 76420-0760 |
Kit Epidural|infiltration|intra-Articular|intramuscular|topical |
Asclemed USA, Inc. | Rx |
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in products
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
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