FDAFDA · Food and drugs·Recall number D-1498-2019
DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.
Published July 31, 2019 · Recall initiated: June 21, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pharma-Natural Inc.
- Distributor
- Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
- Lot
- All lots remaining within expiry.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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