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 mgGuaifenesin 300 mg) in each 5ml teaspoon4 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.
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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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