Why it was recalled
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Product description
PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-019-14), b) 2 Oz (NDC 69804-019-15), and c) 4 Oz (NDC 69804-019-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
Lot numbers, UPCs & expiration codes
Lot # 1213, Exp 06/05/2023
Where it was sold
Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com
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-1857-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 9, 2019
- FDA report date
- Sep 25, 2019
- Quantity
- 109.64 ounces total
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ridge Properties, LLC
Original FDA data
Every field from FDA enforcement report D-1857-2019, exactly as published.
Show all FDA fields
- City
- Salem
- State
- OR
- Status
- Terminated
- Country
- United States
- Event ID
- 83538
- Address
- 4995 Ridge Dr NE
- Code information
- Lot # 1213, Exp 06/05/2023
- Postal code
- 97301-7475
- Report date
- Sep 25, 2019
- Product type
- Drugs
- Recall number
- D-1857-2019
- Classification
- Class II
- Recalling firm
- Ridge Properties, LLC
- Product quantity
- 109.64 ounces total
- Termination date
- Jul 12, 2023
- Reason for recall
- Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-019-14), b) 2 Oz (NDC 69804-019-15), and c) 4 Oz (NDC 69804-019-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
- Distribution pattern
- Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com
- Recall initiation date
- Aug 9, 2019
- Initial firm notification
- Press Release
- Center classification date
- Sep 13, 2019