Home / Recalls / Ridge Properties, LLC / D-0086-2018

D-0086-2018 Class II Terminated

Recalled by Ridge Properties, LLC — Salem, OR

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 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

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

Other recalls by Ridge Properties, LLC

  • D-1858-2019 Class II — Superior Pain & Itch Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 6980 (August 9, 2019)
  • D-1856-2019 Class II — PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in (August 9, 2019)
  • D-1860-2019 Class II — Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-074-0 (August 9, 2019)
  • D-1861-2019 Class II — Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804- (August 9, 2019)
  • D-1857-2019 Class II — PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packag (August 9, 2019)
  • D-1859-2019 Class II — Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC (August 9, 2019)
  • D-0087-2018 Class II — Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804 (November 3, 2017)
  • D-0088-2018 Class II — Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine (November 3, 2017)
  • D-0090-2018 Class II — Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4% (November 3, 2017)
  • D-0089-2018 Class II — Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1 (November 3, 2017)