FDARecalled Sep 4, 2024 · #D-0646-2024
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 ...
Hazard
Class II — temporary health risk
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Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. Classification: Class II Distribution: Nationwide in the USA and Puerto Rico
Product details
- Product
- 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.
- Type
- Drugs
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Model numbers
- 55111-682-01, 55111-682-05
- UPCs
- —