Boehringer Ingelheim Roxane Inc recalls FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories

Recalled October 21, 2015 · FDA recall D-0012-2016 · Boehringer Ingelheim Roxane

Hazard

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. · FDA Class III

Units

5,160 bottles

Sold at

Nationwide and Puerto Rico

Description

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.

Product

FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2.

Manufacturer(s)

Boehringer Ingelheim Roxane Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →