Drug product

Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.

D-0086-2024

October 13, 2023

Class II

Product summary

Firm: Dr. Reddy's Laboratories, Inc.
Event: Event 93225
Status: Terminated
Classification: Class II
Quantity: 1,656 bottles
Official record key: drug-enforcement:D-0086-2024

Official wording

Reason: Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.

Code information: Lot # C2305569, Exp. date 03/31/2026

Distribution pattern: Nationwide

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

Foreign Tablet