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.
Product Mix-up: Incorrect Product Formulation
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.
LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1
Drug: Lidocaine
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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Labeling Not Elsewhere Classified: Misbranding.
Labeling Not Elsewhere Classified: Misbranding.
Labeling Not Elsewhere Classified: Misbranding.
Labeling Not Elsewhere Classified: Misbranding.
Free recall alerts
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.