Lotemax Gel
FDA Recall NDC 24208-503
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Lotemax (NDC 24208-503). A significant event, classified as Class III, was initiated on Jun 17, 2019 by Bausch & Lomb Incorporated. The reported reason for this action was: "Failed Stability Specifications: Out of specification for viscosity."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Stability Specifications: Out of specification for viscosity.
Jun 17, 2019
Jun 19, 2019
170832 bottles
Recall Profile & Regulatory Data
Event ID
83093
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Bausch & Lomb
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Sep 24, 2021
Product Description
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.
Batch or Lot Expiration Information
Lot# s: 282611; 283431; 283441; 283451, Exp. 10/2019; 282971; 282981; 283611; 283621; 283631, Exp. 11/2019.
Affected Packages Involved in this Recall
24208-503-07Product
24208-503-48Product
24208-503-96Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
