Drug recall D-0646-2024
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.
Reason for recall
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Lots and codes
a)NDC 55111-682-01 Lots C2207529, Exp 5/31/2026; C2210993, Exp 9/30/2026. b)NDC 55111-682-05 Lots C2207530, Exp 5/31/2026; C2210992, C2210994, Exp 9/30/2026; C2213304, C2213305, Exp 11/30/2026.
Recall details
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Quantity
- 14940 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 6, 2024
Related products
- Ibu – drug information
- NDC 55111-682 Ibu · Ibuprofen 400 mg/1 · Dr. Reddy's Laboratories Limited
- NDC 55111-683 Ibu · Ibuprofen 600 mg/1 · Dr. Reddy's Laboratories Limited
- NDC 55111-684 Ibu · Ibuprofen 800 mg/1 · Dr. Reddy's Laboratories Limited