D-0088-2018 Class II Terminated
FDA drug recall D-0088-2018 was initiated by Ridge Properties, LLC on Nov 3, 2017 and is designated Class II. Reason for recall: GMP Deviations: inadequate manufacturing control processes The recall status is terminated (terminated Jan 14, 2019).
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 29, 2017
- Initiation Date
- Nov 3, 2017
- Termination Date
- Jan 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0088-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026