Reported May 10, 2023 · Terminated

Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated…

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?

  • Simvastatin USP 40 mg, Rx only, Intas Pharm
  • Limited Ahmedabad 380 054 India Pkg ByPD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)
Lot codes and dates

9 of 9 products

Products covered by this recall
#Product as published
1A22A17, D22C21 Exp. 07/31/23
2K22D89, L22B26, L22D14 Exp. 03/31/24
3L22D96 Exp. 04/30/24
4L21E06 Exp. 05/31/23
5B22C05, D22B91, E22C82 Exp. 07/31/23
6G22B03 G22B79, H22A30, J22B81 Exp. 08/31/23
7J22F27, K22B37, K22B88 Exp. 10/31/23
8L22D32 Exp. 03/31/24
9B23E07 Exp. 04/30/24
Amount recalled
393 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, 8:38 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.