Drug Enforcement D-0260-2024

Failed Dissolution Specifications

Status

Terminated

Classification

Class II

Report Date

January 31, 2024

Termination Date

July 1, 2025

Product Information

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
Product quantity
396 50-count bottles
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Strides Pharma Inc.
Address
2 Tower Center Blvd Ste 1102, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0260-2024
Event ID
93703
Recall initiation date
December 29, 2023
Center classification date
January 24, 2024
Code info
Lot #: 7253092B, Exp Date 09/30/2025
More code info
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