FDA-Drug2015-10-21Class III
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.
Boehringer Ingelheim Roxane Inc
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.
Sold states
Nationwide and Puerto Rico
Affected count
5,160 bottles
Manufactured in
1809 Wilson Rd, N/A, Columbus, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0012-2016Don't want to check this manually?
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