Recalls / Class II
Class IID-0086-2018
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
- Affected lot / code info
- All batches and lots, exp 10/17/2018. Not all batches were assigned lot numbers
Why it was recalled
GMP Deviations: inadequate manufacturing control processes
Recalling firm
- Firm
- Ridge Properties, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 4995 Ridge Dr NE, N/A, Salem, Oregon 97301-7475
Distribution
- Quantity
- N/A
- Distribution pattern
- Product distributed throughout United States.
Timeline
- Recall initiated
- 2017-11-03
- FDA classified
- 2017-11-21
- Posted by FDA
- 2017-11-29
- Terminated
- 2019-01-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0086-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.