FDA recall D1151-2015

Product

Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811. NDC 0603-3432-21.

Reason for recall

Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-06-18

Report date

2015-07-08

Termination date

2016-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D1151-2015