D-0090-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 29, 2017
- Initiation Date
- November 3, 2017
- Termination Date
- January 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm (NDC 69804-014-06), and 2 oz Balm(NDC 69804-014-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com
Reason for Recall
GMP Deviations: inadequate manufacturing control processes
Distribution Pattern
Product distributed throughout United States.
Code Information
All batches and lots, exp 10/17/2018. Not all batches were assigned lot numbers