FDA recall D-1405-2015

Product

ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28

Reason for recall

Failed Tablet/Capsule Specifications; report of oversized and discolored tablets

Distribution

Nationwide and PR

Key facts

Status

Terminated

Initiation date

2015-07-20

Report date

2015-09-09

Termination date

2016-03-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1405-2015