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 for recall: Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Recall initiated: 20230627
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated