Reported May 10, 2023 · Terminated
Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx…
PD-Rx 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: PD-Rx Pharmaceuticals, Inc. · 727 N Ann Arbor Ave · Oklahoma City, OK · 73127-5822
Is this the product you have?
- Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm
- Limited Ahmedabad 380 054 India Pkg ByPD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
- Lot codes and dates
- Lots
L22C80I22D93K21C72 Exp. 11/30/23A23A90B23A09 Exp. 07/31/24K22C33 Exp. 05/31/24G22E88G22F66I22E27C22B27D22B94E22C71 Exp. 02/28/24I21E36 Exp. 09/30/23
- Lots
- Amount recalled
- 352 bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP deviations.
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.
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