Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science...

FDA Recall #D-0260-2024 — Class II — December 29, 2023

Recall #D-0260-2024 Date: December 29, 2023 Classification: Class II Status: Terminated

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

Recalling Firm

Strides Pharma Inc. — East Brunswick, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

396 50-count bottles

Distribution

Nationwide in the USA

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated