FDA recall D-0260-2024

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

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-12-29

Report date

2024-01-31

Termination date

2025-07-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0260-2024