Status
Terminated
Drug Enforcement D-0086-2024
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.
Classification
Class II
Report Date
November 15, 2023
Termination Date
September 9, 2024
Product Information
- 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.
- Product quantity
- 1,656 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Address
-
107 College Rd E
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0086-2024
- Event ID
- 93225
- Recall initiation date
- October 13, 2023
- Center classification date
- November 3, 2023
- Code info
- Lot # C2305569, Exp. date 03/31/2026
- More code info
- —