FDAFDA · Food and drugs·Recall number D-1503-2019
Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.4 g) jar, Distributed by: Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04.
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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