Drug 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.
D-1507-2019
Product summary
- Event
- Event 83190
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5273 roll on bottles
- Official record key
drug-enforcement:D-1507-2019
Official wording
Reason: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Code information: All lots remaining within expiry.
Distribution pattern: Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations