Drug 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
D-0260-2024
Product summary
- Event
- Event 93703
- Status
- Terminated
- Classification
- Class II
- Quantity
- 396 50-count bottles
- Official record key
drug-enforcement:D-0260-2024
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: 7253092B, Exp Date 09/30/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications