FDA-Drug2023-07-19Class III
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
Hazard
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Sold states
Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
Affected count
3,096 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0899-2023More Lupin Pharmaceuticals Inc. recalls
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