Reported Jul 31, 2019 · Terminated

DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle,…

Pharma-Natural 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: Pharma-Natural Inc. · 14500 Nw 60th Ave Bldg 7f · Miami Lakes, FL · 33014

Is this the product you have?

    • DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg
    • Guaifenesin 300 mg) in each 5ml teaspoon
    • 4 FL OZ (120 mL) bottle
  • Distributed byPamby Dist., Miami, FL 33414, NDC 63708-121-04
Lot codes and dates
  • All lots remaining within expiry.
Amount recalled
500 bottles

This recall covers 16 products

The agency filed one notice per product. You are reading one of them; the other 15 are below.

3 more are in the archive.

Where it was sold

Why it was recalled

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

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.

Free recall alerts

Get alerted about new Pharma-Natural Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 27, 2021 · Data as of Sep 19, 8:05 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.