D-0088-2018 Class II Terminated
FDA drug recall D-0088-2018 was initiated by Ridge Properties, LLC on November 3, 2017 and is designated Class II. Reason for recall: GMP Deviations: inadequate manufacturing control processes The recall status is terminated (terminated January 14, 2019). Affected quantity: N/A.
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 Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz Spray (NDC 69804-015-08), 1 oz Spray (NDC 69804-015-07), 2 oz Spray (NDC 69804-015-01) and 4 oz Spray (NDC 69804-015-04) bottles, 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