FDAFDA · Food and drugs·Recall number D-0086-2024
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.
Published November 15, 2023 · Recall initiated: October 13, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MONTELUKAST SODIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Nationwide
- Lot
- Lot # C2305569, Exp. date 03/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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