Workvie Pain Relieving Roll On (Pharma-Natural) – manufacturing deviation (2019)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Pharma-Natural Inc.
Lot Codes / Batch Numbers
All lots remaining within expiry.
Products Sold
All lots remaining within expiry.
Pharma-Natural Inc. is recalling Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g) roll o due to CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufactur. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026