Status
Terminated
Drug Enforcement D-0171-2023
Failed Dissolution Specification
Classification
Class II
Report Date
February 1, 2023
Termination Date
August 15, 2024
Product Information
- Product description
- Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-05.
- Product quantity
- 2628 bottles
- Reason for recall
- Failed Dissolution Specification
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Ascend Laboratories, LLC
- Address
-
339 Jefferson Rd Ste 101, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0171-2023
- Event ID
- 91442
- Recall initiation date
- January 5, 2023
- Center classification date
- January 20, 2023
- Code info
- Lot#: 21141321, 21141322, Exp 01/31/2023.
- More code info
- —