Qualitest Pharmaceuticals recalls Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vint…

Recall date

June 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D1151-2015

FDA classification

Class III

Brand / firm

Qualitest Pharmaceuticals

Sold / distributed

Nationwide

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.