FDAFDA · Food and drugs·Recall number D-1497-2019
GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl oz (474 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-650-16.
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
- Brand
- GENCONTUSS
- Manufacturer
- Pharma-Natural Inc.
- Distributor
- Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
- UPC
- 0352083650161
- Lot
- All lots remaining within expiry.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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