Drug Recall: IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tab
Dr. Reddy's Laboratories, Inc. · August 6, 2024
Reason for Recall
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Product Description
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle.
Distribution
Nationwide in the USA and Puerto Rico
States Affected
NATIONWIDE
Quantity Affected
14940 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0646-2024
Status: ongoing
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