Recalls / Class II
Class IID-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
- Brand name
- Methoxsalen
- Generic name
- Methoxsalen
- Active ingredient
- Methoxsalen
- Route
- Oral
- NDC
- 64380-752
- FDA application
- ANDA202687
- Affected lot / code info
- Lot #: 7253092B, Exp Date 09/30/2025
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Strides Pharma Inc.
- Manufacturer
- Strides Pharma Science Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd Ste 1102, N/A, East Brunswick, New Jersey 08816-1100
Distribution
- Quantity
- 396 50-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-12-29
- FDA classified
- 2024-01-24
- Posted by FDA
- 2024-01-31
- Terminated
- 2025-07-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0260-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.