December 2023 FDA Recall Methoxsalen by Strides Pharma Inc.
D-0260-2024 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Strides Pharma Inc. on December 29, 2023 for the product Methoxsalen. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0260-2024
Failed Dissolution Specifications
12-29-2023
01-31-2024
396 50-count bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Strides Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
07-01-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
