PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 31, 2024 Initiated: December 29, 2023 #D-0260-2024

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

Details

Recalling Firm
Strides Pharma Inc.
Units Affected
396 50-count bottles
Distribution
Nationwide in the USA
Location
East Brunswick, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Strides Pharma Inc.. Units affected: 396 50-count bottles.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on January 31, 2024. Severity: Moderate. Recall number: D-0260-2024.