FDA-Drug2019-07-31Class II
Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g) roll on bottle, Exclusively Distributed by: Marketite, LLC., Coral Gables, FL 33134, NDC 72393-201-25.
Pharma-Natural Inc.
Hazard
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Sold states
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Affected count
5273 roll on bottles
Manufactured in
14500 Nw 60th Ave Bldg 7f, N/A, Miami Lakes, FL, United States
Products
Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g) roll on bottle, Exclusively Distributed by: Marketite, LLC., Coral Gables, FL 33134, NDC 72393-201-25.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1507-2019Don't want to check this manually?
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