Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #: 7253092B, Exp Date 09/30/2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0260-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 29, 2023
- FDA report date
- Jan 31, 2024
- Quantity
- 396 50-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Strides Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0260-2024, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 93703
- Address
- 2 Tower Center Blvd Ste 1102
- Code information
- Lot #: 7253092B, Exp Date 09/30/2025
- Postal code
- 08816-1100
- Report date
- Jan 31, 2024
- Product type
- Drugs
- Recall number
- D-0260-2024
- Classification
- Class II
- Recalling firm
- Strides Pharma Inc.
- Product quantity
- 396 50-count bottles
- Termination date
- Jul 1, 2025
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 29, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 24, 2024