Drug product
Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC 69804-008-06), 1 oz Balm (NDC 69804-008-05), 2 oz Balm(NDC 69804-008-02), and 4 oz Balm(NDC 69804-008-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com
D-0086-2018
Product summary
- Event
- Event 78462
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0086-2018
Official wording
Reason: GMP Deviations: inadequate manufacturing control processes
Code information: All batches and lots, exp 10/17/2018. Not all batches were assigned lot numbers
Distribution pattern: Product distributed throughout United States.
Derived failure modes
-
Manufacturing or process control
GMP Deviations