PRE-TAT Lidocaine Gel Recalled for Microbial Contamination
Ridge Properties, LLC is recalling PRE-TAT lidocaine gel due to microbial contamination and lidocaine assay issues. Consumers should stop using the product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves microbial contamination, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Ridge Properties, LLC is recalling PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%. The product is packaged in 1 oz, 2 oz, and 4 oz bottles. The recall involves Lot # 1213 with an expiration date of 06/05/2023.
The recall was initiated because the products were found to be contaminated and above specification for lidocaine assay. The agency classification for this recall is Class II.
The product was distributed nationwide in the USA via internet sales through Amazon.com, ebay.com, Walmart.com, tatbalm.net, and Naturallyhl.com. Consumers should stop using the recalled product and contact the manufacturer for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Ridge Properties, LLC
- Category
- Drug — Topical Anesthetic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 1213
- Exp 06/05/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Ridge Properties, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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