Recall: D-0899-2023

Class III - Minor Violations

Class IIIClassification

2023-06-27Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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.

Distribution

Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.