FUROSEMIDE Tablets USP recalled over manufacturing violations

Recall date

September 25, 2015

Source

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

Official notice title

Boehringer Ingelheim Roxane Inc recalls FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratorie…

Recall number

D-0011-2016

FDA classification

Class III

Brand / firm

Boehringer Ingelheim Roxane Inc

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.

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

What was recalled

FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.