Status
Terminated
Drug Enforcement D-0899-2023
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Classification
Class III
Report Date
July 19, 2023
Termination Date
March 12, 2024
Product Information
- Product description
- Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03
- Product quantity
- 3,096 bottles
- Reason for recall
- Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
Location & Firm
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Address
-
Harborplace Tower, 111 S Calvert St Fl 21st
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0899-2023
- Event ID
- 92618
- Recall initiation date
- June 27, 2023
- Center classification date
- July 7, 2023
- Code info
- Lot #: A102887, Exp. 6/2023
- More code info
- —