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.
Reason for recall: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated: 20190621
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated