Product: Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03
Reason for recall: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Recall initiated: 20160219
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated