Lupin Pharmaceuticals Inc. recalls Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Balti
Recalled July 19, 2023 · FDA recall D-0899-2023 · Lupin Pharmaceuticals
Hazard
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study. · FDA Class III
Units
3,096 bottles
Sold at
Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
Description
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Product
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
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →