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
    • L22C80
    • I22D93
    • K21C72 Exp. 11/30/23
    • A23A90
    • B23A09 Exp. 07/31/24
    • K22C33 Exp. 05/31/24
    • G22E88
    • G22F66
    • I22E27
    • C22B27
    • D22B94
    • E22C71 Exp. 02/28/24
    • I21E36 Exp. 09/30/23
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 30, 2024 · Data as of Sep 19, 8:08 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.