Class III Recall

Lupin Pharmaceuticals Inc.

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
Reason
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Classification
Class III
Status
Terminated
Lot
Lot #: A102887, Exp. 6/2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.