FDA recall D-1572-2014

Qualitest Pharmaceuticals · Class II · drug

Product

OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21

Reason for recall

Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-08-27
Report date: 2014-09-10
Termination date: 2016-02-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1572-2014