FDA-Drug2024-09-04Class II
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.
Dr. Reddy's Laboratories, Inc.
Hazard
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
103,298 bottles
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0644-2024Don't want to check this manually?
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