Methoxsalen Capsule, Liquid Filled
FDA Recall NDC 64380-752
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 Methoxsalen (NDC 64380-752). A significant event, classified as Class II, was initiated on Dec 29, 2023 by Strides Pharma Science Limited. The reported reason for this action was: "Failed Dissolution Specifications"
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 II Terminated
Failed Dissolution Specifications
Dec 29, 2023
Jan 31, 2024
396 50-count bottles
Recall Profile & Regulatory Data
Event ID
93703
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Strides Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jul 01, 2025
Product Description
Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-752-16
Batch or Lot Expiration Information
Lot# : 7253092B, Exp Date 09/30/2025
Affected Packages Involved in this Recall
64380-752-16Product
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.
