Status
Ongoing
Drug Enforcement D-0581-2025
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Classification
Class II
Report Date
August 20, 2025
Termination Date
—
Product Information
- Product description
- Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10
- Product quantity
- 16,672 1000-count bottles
- Reason for recall
- CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide in the USA.
Location & Firm
- Recalling firm
- Westminster Pharmaceuticals LLC
- Address
-
1321 Murfreesboro Pike Ste 607, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0581-2025
- Event ID
- 97395
- Recall initiation date
- August 6, 2025
- Center classification date
- August 12, 2025
- Code info
- Batch # R55230021, R55230031, R55230041, Exp Date: 9/30/25; Batch # R55230051, R55230061, R55230071, R55230081, R55230091, R55230101, R55230111, R55230121, R55230131, R55230141, Exp Date: 10/31/2025; Batch # R55230151, Exp Date: 11/30/25; Batch # R55240011, Exp Date: 12/31/25; Batch # R55240021, R55240031, R55240041, R55240051, R55240061, Exp Date: 6/30/26; Batch # R55240071, R55240081, R55240091, R55240101, R55240111, R55240121, Exp Date: 7/31/26
- More code info
- —