FDA 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.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Ongoing

Initiation date

2024-08-06

Report date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0646-2024