Why it was recalled
GMP Deviations: inadequate manufacturing control processes
Product description
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
Lot numbers, UPCs & expiration codes
All batches and lots, exp 10/17/2018. Not all batches were assigned lot numbers
Where it was sold
Product distributed throughout United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0089-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 3, 2017
- FDA report date
- Nov 29, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ridge Properties, LLC
Original FDA data
Every field from FDA enforcement report D-0089-2018, exactly as published.
Show all FDA fields
- City
- Salem
- State
- OR
- Status
- Terminated
- Country
- United States
- Event ID
- 78462
- Address
- 4995 Ridge Dr NE
- Code information
- All batches and lots, exp 10/17/2018. Not all batches were assigned lot numbers
- Postal code
- 97301-7475
- Report date
- Nov 29, 2017
- Product type
- Drugs
- Recall number
- D-0089-2018
- Classification
- Class II
- Recalling firm
- Ridge Properties, LLC
- Termination date
- Jan 14, 2019
- Reason for recall
- GMP Deviations: inadequate manufacturing control processes
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product distributed throughout United States.
- Recall initiation date
- Nov 3, 2017
- Initial firm notification
- Press Release
- Center classification date
- Nov 21, 2017