Recall: D-0011-2016

Class III - Minor Violations

Class IIIClassification

2015-09-25Initiated

TerminatedStatus

Boehringer Ingelheim Roxane InFirm

Product

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.

Reason

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.

Distribution

Nationwide and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.