D-0260-2024 Class II Terminated

Recalled by Strides Pharma Inc. — East Brunswick, NJ

FDA drug recall D-0260-2024 was initiated by Strides Pharma Inc. on December 29, 2023 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated July 1, 2025). Affected quantity: 396 50-count bottles.

Recall Details

Product Type
Drugs
Report Date
January 31, 2024
Initiation Date
December 29, 2023
Termination Date
July 1, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
396 50-count bottles

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

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 7253092B, Exp Date 09/30/2025