FDA recall D-0899-2023

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2023-06-27

Report date

2023-07-19

Termination date

2024-03-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0899-2023