COMPANY ANNOUNCEMENT
Ridge Properties DBA Pain Relief Naturally Issues Voluntary Nationwide Recall of all Lots of Naturally HL Bedsore Cream, Pretat by TAT Balm Carbomer Free Gel, & All Naturally HL Hemorrhoid Products Due to Manufacturing Concerns at the Facility
This recall has been completed and FDA has terminated this recall.
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Read Announcement View Product PhotosSummary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
Over-the-Counter Drugs - Reason for Announcement:
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Recall Reason DescriptionManufacturing Concerns
- Company Name:
- Ridge Properties DBA Pain Relief Naturally
- Brand Name:
-
Brand Name(s)Ridge Properties DBA Pain Relief Naturally
- Product Description:
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Product DescriptionPain and itch relief products
Company Announcement
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, Salem, Oregon to the consumer level. These products are being recalled after an 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
Product | Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine |
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Lots Recalled | All lots sold before 10/17/2017 |
Expiration Dates | All products expiring before 10/17/2018 |
NDC #'s | 68904-014, 69804-015, 69804-024 |
Use | For temporary relief of pain and itching |
Container Type | Black jars and bottle |
Sizes | 1/2 ounce, 1 ounce, 2 ounce and 4 ounce |
Strenght | 4% |
Product | Extra Strength Naturally HL Bedsore Relief Cream With Lidocaine |
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Lots Recalled | All lots sold before 10/17/2017 |
Expiration Dates | All products expiring before 10/17/2018 |
NDC #'s | 69804-008 |
Use | For temporary relief of pain and itching |
Container Type | Black jars and bottle |
Sizes | 1/2 ounce, 1 ounce, 2 ounce and 4 ounce |
Strenght | 4% |
Product | Extra Strength PreTAT by TAT Balm Carbomer Free GelWith Lidocaine |
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Lots Recalled | All lots sold before 10/17/2017 |
Expiration Dates | All products expiring before 10/17/2018 |
NDC #'s | 69804-018 |
Use | For temporary relief of pain and itching |
Container Type | Black jars and bottle |
Sizes | 1/2 ounce, 1 ounce, 2 ounce and 4 ounce |
Strenght | 4% |
The products were distributed nationwide via the internet at amazon.com, ebay.com, naturallyhl.com, and tatbalm.net.
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.
Consumers with questions regarding this recall can contact Ridge Properties DBA Pain Relief Naturally by phone at 877-906-4806 or by email at PRNCustomerCare@Gmail.com , Monday-Friday 9am-5pm Pacific Time Zone. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
All recalled products should be shipped to the following address
Pain Relief Naturally
ATTN RECALL
4995 Ridge Dr NE
Salem, OR, 97301
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm1
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm2 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.