Ridge Properties DBA Pain Relief Naturally Products: Recall - Manufacturing Concerns at the Facility
Including: Naturally HL Bedsore Relief Cream, Extra Strength PreTAT by TAT Balm Carbomer Free Gel, and Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine
AUDIENCE: Consumer, Pharmacy
ISSUE: Ridge Properties DBA Pain Relief Naturally is voluntarily recalling all lots within expiry of Naturally HL Bedsore Relief Cream, Extra Strength PreTAT by TAT Balm Carbomer Free Gel, and Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine manufactured by Ridge Properties dba Pain Relief Naturally, to the consumer level. FDA inspection found significant violations of current good manufacturing practice regulations.
Manufacturing practices that are not in adequate control represent the possibility of risk being introduced into the manufacturing process in decreased quality and consistency (i.e., the safety, identity, strength, quality and purity). Ridge Properties has received reports of subpotency in Extra Strength PreTAT by TAT Balm Carbomer Free Gel.
BACKGROUND: The products were distributed nationwide via the internet at amazon.com, ebay.com, naturallyhl.com, and tatbalm.net.
RECOMMENDATION: Ridge Properties DBA Pain Relief Naturally is notifying its distributors and customers by National Press Release and is arranging for return of all recalled products. Consumers that have Naturally HL Bedsore Cream, Pretat by TAT Balm Carbomer Free Gel, & All Naturally HL Hemorrhoid products, which is being recalled should stop using & return directly to Ridge Properties DBA Pain Relief Naturally or discard the products.Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178