Reported Mar 8, 2023 · Terminated
Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as
Accord Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446
Is this the product you have?
Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8 |
| 2 | 90-count bottle NDC 16729-119-15 UPC 3 16729 11915 3 |
| 3 | 1,000-count bottle NDC 16729-119-17 UPC 3 16729 11917 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA |
- Lot codes and dates
20 of 20 products
Products covered by this recall # Product as published 1 R2000831, Exp. Date 11/30/2023 2 R2000832, Exp. Date 11/30/2023 3 R2200661, Exp. Date 5/31/2025 4 R2000836, R2000837, R2000838, R2000840, R2000842, R2000835, R2000841, R2000833, Exp. Date 11/30/2023 5 R2100310, R2100311, R2100314, R2100312, R2100313, R2100315, R2100316, R2100317, R2100318, Exp. Date 2/29/2024 6 R2100859, Exp. Date 5/31/2024 7 R2100940, R2100993, Exp. Date 7/31/2024 8 R2000473, Exp. Date 8/31/2023 9 R2000517, Exp. Date 9/30/2023 10 R2100036, R2100005, R2100037, R2100002, R2100040, R2100044, R2100045, R2100039, R2100038, R2100104, R2100047, R2100048, R2100046, R2100049, R2100056, R2100057, R2100101, R2100058, R2100050, R2100103, R2100102, R2100116, R2100108, R2100105, R2100123, R2100117, R2100118, R2100121, R2100122, R2100128, R2100119, R2100124, Exp. Date 12/31/2023 11 R2100124, R2100182, R2100184, R2100183, R2100188, R2100189, R2100186, R2100222, R2100197, R2100198, R2100203, R2100192, R2100196, R2100202, R2100199, R2100200, R2100223, R2100224, R2100225, R2100226, R2100228, R2100245, R2100227, R2100230, R2100229, Exp. Date 1/31/2024 12 R2100246, R2100253, R2100249, R2100251, R2100248, R2100263, R2100254, R2100264, R2100265, R2100266, R2100255, R2100256, R2100257,Exp. Date 2/29/2024 13 R2100445, R2100446, R2100449, R2100450, R2100451, Exp. Date 3/31/2024 14 R2100544, R2100545, R2100549, R2100550, R2100567, R2100568, R2100574, R2100576, R2100577, Exp. Date 4/30/2024 15 R2100594, R2100610, R2100600, R2100624, R2100626, R2100662, R2100661, R2100629, R2100776, R2100693, R2100681, R2100684, Exp. Date 5/31/2024 16 R2100725, R2100724, R2100726, R2100816, R2100804, R2100815, R2100834, R2100841, Exp. Date 6/30/2024 17 R2200188, R2200196, R2200195, Exp. Date 1/31/2025 18 R2200368, R2200366, R2200503, Exp. Date 3/31/2025 19 R2200659, R2200660, R2200751, R2200759, R2200761, R2200763, Exp. Date 5/31/2025 20 R2201016, R2201014, Exp. Date 7/31/2025 - Amount recalled
- 665,469 bottles
This recall covers 67 products
The agency filed one notice per product. You are reading one of them; the other 66 are below.
54 more are in the archive.
Where it was sold
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Accord Healthcare, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.