Dr.Reddy’s Recall Several Lots of Ibuprofen Tablets for Impurities

Dr.Reddy’s laboratories Inc (DRL) has initiated recall of 50 batches of Ibuprofen tablets in US market. DRL is recalling Ibuprofen tablets of three different strengths – 800mg, 600mg and 400mg.

The recall is initiated based on the results observed in the 18 month long term stability study samples stored at 25±2°C and 60±5% RH. In the stability studies out of specification (OOS) results were observed for degradation impurities at levels of 0.13% and 0.11% against specification limit of 0.10% for unknown impurity.

The level of impurities being slightly above the specification limits, it may not significantly affect the medications effectiveness or have a significant adverse impact. The recall is classified as Class II. As per USFDA a Class II recall is a “situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote”.

• USFDA Enforcement report
• California State Board of Pharmacy Recall Alert