D-0899-2023 Class III Terminated
FDA drug recall D-0899-2023 was initiated by Lupin Pharmaceuticals Inc. on June 27, 2023 and is designated Class III. Reason for recall: Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study. The recall status is terminated (terminated March 12, 2024). Affected quantity: 3,096 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 19, 2023
- Initiation Date
- June 27, 2023
- Termination Date
- March 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,096 bottles
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
Reason for Recall
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Distribution Pattern
Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
Code Information
Lot #: A102887, Exp. 6/2023