Reported Apr 12, 2023 · Ongoing
Montelukast Sodium Tablets, USP, 10 mg, packaged in
Preferred Pharmaceuticals, 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: Preferred Pharmaceuticals, Inc. · 1250 N Lakeview Ave Ste O · Anaheim, CA · 92807-1801
Is this the product you have?
Montelukast Sodium Tablets, USP, 10 mg, packaged in
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 30-count bottle (NDC 68788-9438-3) |
| 2 | 60-count bottle (NDC 68788-9438-6) |
| 3 | 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703. |
- Lot codes and dates
- a) Lot
F3021DExp 12/31/2023
- Lot
L0722TExp 5/31/2025
- b) Lot
F1021IExp 12/31/2023
- c) Lot
H1721RExp 12/31/2023
- Lot
L0722EExp 5/31/2025
- a) Lot
- Amount recalled
- a) 266 Bottles, b) not reported, c) 216 Bottles
This recall covers 20 products
The agency filed one notice per product. You are reading one of them; the other 19 are below.
7 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their 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 Preferred Pharmaceuticals, 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.