D-0086-2024 Class II Terminated
FDA drug recall D-0086-2024 was initiated by Dr. Reddy's Laboratories, Inc. on October 13, 2023 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated September 9, 2024). Affected quantity: 1,656 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 15, 2023
- Initiation Date
- October 13, 2023
- Termination Date
- September 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,656 bottles
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
Lot # C2305569, Exp. date 03/31/2026