Reported Jun 12, 2013 · Terminated

AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC…

TG United, 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: TG United, Inc. · 16275 Aviation Loop Dr · Brooksville, FL · 34604-6805

Is this the product you have?

    • AMBI 40PSE/400GFN
    • 100 tablet bottle
    • OTC
  • Manufactured forAMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01
Lot codes and dates
    • Lot # 12C007 Exp. 02/14
    • Lot # 12C008 Exp. 02/14
Amount recalled
886 bottles - 100-count tablets

This recall covers 44 products

The agency filed one notice per product. You are reading one of them; the other 43 are below.

31 more are in the archive.

Where it was sold

Why it was recalled

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

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

Notice updated Sep 30, 2016 · Data as of Sep 19, 7:18 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.