Reported May 3, 2023 · Ongoing

Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC…

Northwind Pharmaceuticals LLC

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: Northwind Pharmaceuticals LLC · 4838 Fletcher Ave Ste 1000 · Indianapolis, IN · 46203-1642

Is this the product you have?

  • Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only
  • Repackaged ByNorthwind Pharmaceuticals, Indianapolis, IN 46203
Lot codes and dates
    • a) Lot #: F113892002
    • Exp. Date 08/31/2023
    • F113892201
    • Exp. Date 11/30/2023 b) Lot #: F113892001
    • Exp. Date 08/31/2023
    • F113892202
    • Exp. Date 11/30/2023
    • F113892203
    • Exp. Date 12/31/2023
Amount recalled
a)164 bottles; b) 198 bottles

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 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.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 6:37 PM UTC

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