FDA recall D-0331-2015

Qualitest Pharmaceuticals · Class III · drug

Product

ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

Reason for recall

Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-12-22
Report date: 2015-01-14
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-0331-2015