Multi-event November 2017 FDA Recall Drug by Ridge Properties, Llc

This Multi-event Class II drug recall was voluntarily initiated by Ridge Properties, Llc on November 3, 2017 for the product Drug. The FDA reported the reason for recall as gmp deviations. The product was distributed in Product distributed throughout United States. and the recall is currently terminated.

Reported Recall Events

D-0089-2018 TERMINATED D-0087-2018 TERMINATED D-0088-2018 TERMINATED D-0086-2018 TERMINATED D-0090-2018 TERMINATED

Recall Number: D-0089-2018

Reason for Recall
GMP Deviations: inadequate manufacturing control processes
Initiated
11-03-2017
Reported
11-29-2017
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78462
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ridge Properties, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product distributed throughout United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-14-2019
Product Description About Product Description
Full technical description of the product.
Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 oz Liquid Gel (NDC 69804-024-14), 2 oz Liquid Gel (NDC 69804-024-15), 4 oz Liquid Gel (NDC 69804-024-16) bottles, Manufactured by Pain Relief Naturally, www.Naturally HL.com

Batch or Lot Expiration Information

Lot# All batches and lots, exp 10/17/2018. Not all batches were assigned lot numbers

Recall Number: D-0087-2018

Reason for Recall
GMP Deviations: inadequate manufacturing control processes
Initiated
11-03-2017
Reported
11-29-2017
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78462
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ridge Properties, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product distributed throughout United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-14-2019
Product Description About Product Description
Full technical description of the product.
Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) , 2 oz Gel (NDC 69804-018-11), and 4 oz Gel (NDC 69804-018-12) jars, Manufactured by Pain Relief Naturally, www.Naturally HL.com

Batch or Lot Expiration Information

Lot# All batches and lots, exp 10/17/2018. Not all batches were assigned lot numbers

Recall Number: D-0088-2018

Reason for Recall
GMP Deviations: inadequate manufacturing control processes
Initiated
11-03-2017
Reported
11-29-2017
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78462
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ridge Properties, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product distributed throughout United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-14-2019
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# All batches and lots, exp 10/17/2018. Not all batches were assigned lot numbers

Recall Number: D-0086-2018

Reason for Recall
GMP Deviations: inadequate manufacturing control processes
Initiated
11-03-2017
Reported
11-29-2017
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78462
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ridge Properties, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product distributed throughout United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-14-2019
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# All batches and lots, exp 10/17/2018. Not all batches were assigned lot numbers

Recall Number: D-0090-2018

Reason for Recall
GMP Deviations: inadequate manufacturing control processes
Initiated
11-03-2017
Reported
11-29-2017
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78462
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ridge Properties, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product distributed throughout United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-14-2019
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# All batches and lots, exp 10/17/2018. Not all batches were assigned lot numbers