Pharma-Natural Inc. recalls Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.

Recalled July 31, 2019 · FDA recall D-1503-2019 · Pharma-Natural

Hazard

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

Units

1000 jars

Sold at

Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.

Description

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

Product

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.

Manufacturer(s)

Pharma-Natural Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →