← FDA ENFORCEMENT
D-0260-2024Class II

Strides Pharma Inc.

Recalling firm
Strides Pharma Inc.
Product type
Drug
Status
Terminated
Report date
2024-01-31
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
396 50-count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Dissolution Specifications

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.