PRE-TAT Lidocaine Cream Recalled for Microbial Contamination and Assay Failures
Ridge Properties, LLC is recalling PRE-TAT Lidocaine Cream due to microbial contamination and lidocaine assay levels above specification. The product was sold nationwide via online retailers.
What this means for you
Illness, injury, or structural failure has been reported. 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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as microbial contamination) are categorized as Severe (Score 4), as they are not Class I but involve significant health risks.
Plain-English summary
Ridge Properties, LLC is recalling PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%. The recall involves 1 OZ, 2 OZ, and 4 OZ jars manufactured, packed, and distributed by Pain Relief Naturally in Salem, Oregon. The total quantity recalled is 383.65 ounces.
The recall was initiated because the products were found to be contaminated and above specification for lidocaine assay. This is classified as an FDA Class II recall, indicating a situation that may cause temporary or medically reversible adverse health consequences.
The affected product, Lot # 1222 with an expiration date of 06/14/2023, 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 product and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ (NDC 69804-002-05), b) 2 OZ (NDC 69804-002-02), and c) 4 OZ (NDC 69804-002-03) jars, 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 # 1222
- Exp 06/14/2023
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.
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