FDA recall D-0397-2015

Qualitest Pharmaceuticals · Class II · drug

Product

AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

Reason for recall

Failed tablet specifications: One lot was found to contain oversized tablets.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-02-13
Report date: 2015-03-11
Termination date: 2016-01-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0397-2015